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Surg Endosc (1997) 11: 56–63

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Laparoscopic cholecystectomy in 1994 Results of a prospective survey conducted by SFCERO* on 4,624 cases D. Collet Service de Chirurgie Ge´ne´rale et Digestive, Maison du Haut-Leveˆque, ˆque, Avenue de Magellan, 33604 Pessac Cedex, France Received: 25 January 1996/Accepted: 10 April 1996

Abstract.  Background: In 1996, laparoscopic cholecystectomy is the gold standard for symptomatic cholelithiasis. The results of  this operation as published so far include data on the learning curve of the method. The aim of this study is to evaluate the results results of laparos laparoscopi copicc cholecy cholecyste stecto ctomy my when performed by a large number of surgeons during the year 1994, not taking into account the beginning years in which the technique was being used. prospectively y and  Methods: This study has been carried out prospectivel anonymously among members of SFCERO. All the patients who underwent a cholecystectomy started laparoscopically during 1994 have been included.  Results: Some 4,624 cholecystectomies were performed by 150 surgeons. There were 3,310 females (42.5 ± 19.8 years old) and 1,314 males (56.3 ± 1.61 years old). The conversion rate was 6.9%: 320 operations had to be converted into laparotomy (group II) while 4,261 were performed entirely by laparoscopy (group I). Morbidity was 5% ( N  230)— 4.7% in group I ( N  203) and 8.4% in group II ( N  27). Mortality was 0.2% ( N  9)—namely four intraabdominal complications (three cases of peritonitis and one biliary reoperation), two cardiac failures, and one brain infarction. The causes of death were not specified in two patients. Conclusions: These results show that morbidity and mortality have not changed dramatically since the beginnings of  this technique, whereas the frequency of common bile duct (CBD) injuries has decreased. However, the conversion rate has increa increased sed slight slightly. ly. These These result resultss make make it possib possible le to calculate the risk of conversion and postoperative complication according to the age of the patient and the biliary symptoms.

* SFCERO: Socie´te ´te´ Franc¸aise ¸aise de Chirurgie Endoscopique et Radiologie Ope´ratoire, ´ra toire, dissolved dissolve d in December Decemb er 1994 199 4 to form the th e SFCEL (Socie´te´ Franc¸aise ¸aise de Chirurgie Endoscopique et Laparoscopique) in association with the FDCL

Key words: Gallstones Gallstones — Cholecyste Cholecystectomy ctomy — Surgery — Laparoscopy — Laparoscopic cholecystectomy

After widely—and widely—and sometimes sometimes wisely—cri wisely—critici ticized zed beginnings, after heated debates and the often-uncontrolled publicity through the media, laparoscopic cholecystectomy was officially recognized in 1994 as the treatment of choice for symptomati symptomaticc gallbladde gallbladderr lithiasis lithiasis [16]. Although Although its morbidity and mortality rates are similar to those of open cholecystect lecystectomy, omy, it has the advantage advantage of suppressing suppressing the drawbacks linked to open abdominal surgery: All previous studies have have pointed pointed to a signif significa icantl ntly y shorte shorterr hospit hospital al stay, stay, lesser postoperative pain, and earlier return to work [1, 2, 4, 8, 12–15, 17, 24, 27–29, 31, 33, 36–39]. Yet, the only results published on this procedure so far have come either from highly trained operating teams or from multicenter multicenter studies that took into account account the learning curve of the method. This possible bias may have given rise to a number number of sometim sometimes-e es-exagg xaggera erated ted controve controversie rsiess or even rumors. This is why it seemed necessary, now that this technique has reached the stage of maturity, to evaluate its results among a large community of surgeons, thus providing a sort of ‘‘snapshot’’ of it for the year 1994. This is the objective of this study. Material and methods This survey has been carried out prospectively and anonymously. At the beginning of the survey, the participating surgeons committed themselves to supplying information about all the patients who would undergo laparoscopic cholecystectomy between January 1 and December 31, 1994. A letter of reminder was sent out to them halfway through the year to boost their personal involvement. The form used to collect the data included the patient’s identity, the biliary symptoms, the technique used, the circumstances of the conversion if any, and finally, the postoperative course over 1 month. One separate personal form was completed for each of the patients and was sent anonymously to the person in charge of the survey. Therefore, this is a prospec-

57

Fig. 1. Age groups.

Fig. 2. Length of pneumoperitoneum in group I patients (procedures without conversion).

Table 1. Biliary symptoms

Table 2. Intraoperative appearance of the gallbladder

Symptoms



%

Aspect

No. patients

%

Biliary colic Acute cholecystitis Bile retention syndrome Pancreatitis Biliary ileus Biliary peritonitis Not specified Total

2,988 1,198 208 126 3 2 99 4,624

64.6 25.9 4.5 2.7 0.06 0.06 2.1

Normal Acute inflammation Scleroatrophic Gangrenous cholecystitis Hydrocholecystitis Not seen Tumoral Not specified

2,698 1,284 390 117 9 5 1 120

58.3 27.7 8.4 2.5 0.2 0.1 0.1 2.6

tive consecutive series in which the methodology used does not allow one to know the participant’s previous experience in laparoscopic surgery nor the number of patients who underwent a classical cholecystectomy during the same period of time. The data were collected into a Microsoft Access database. Incomplete or missin missing g answer answerss were were not taken taken into into accoun accountt for the calcul calculati ation on of  percentages. Therefore, the corresponding figures are mentioned in parentheses. The degree of obesity was evaluated by the Body Mass Index (BMI): Weight (kg)/Size (m2). The normal values range from 20 to 30 kg/m2. The obesity is classified as moderate from 30 to 35 kg/m2, and morbid beyond 35 kg/m2. A statistical analysis was carried out on Statistica for linear and multiple regressions and on EGRET for logistical regressions. A value of  p < 0.01 was considered statistically significant.

and in 81.2% of the males (589/725) ( p < 0.01). The frequency of complications was 27.4% (496/1,810) in patients under 50 years of age and 39.1% (1,065/2,718) in those over 50 ( p < 0.01).

 Intraoperative appearance of the gallbladder  (Table (Table 2). The gallbladder had a normal aspect in 83.6% of the patients (2,499/2,9 (2,499/2,988) 88) with noncompli noncomplicate cated d gallstone gallstones; s; however, however, acute inflammation was observed in 78.1% of the patients (936/1,198) with clinical signs of acute cholecystitis.

Conversion into laparotomy

Results Note: The names of the 150 surgeons who participated in this study are listed at the end of this article.

Conversion rate. The procedure was performed entirely by laparoscopy in 4,261 cases (group I) and had to be converted in 320 cases (group II). In 59 cases, the information was not provided. The conversion rate in this series is 6.9%.

 Epidemiological  Epidemiological features

Patients’ age and sex. In 1994, 4,624 patients were operated by 150 surgeons. There were 3,310 females (52.5 ± 19.8 years old) and 1,314 males (56.3 ± 16.1 years old) (Fig. 1). The age difference is statistically significant ( p < 0.01).

(Table 1). Lithiasis Lithiasis was reveale revealed d by com Biliary symptoms (Table plications plications (acute cholecystit cholecystitis, is, symptoms symptoms of biliary biliary retenretention or acute pancreatitis) in 30% of the females (991/2,319)

Circumstances of the conversion (Table (Table 3). In 43 cases, cases, the decision to convert was linked to intraoperative complications: 27 hemorrhages, five common bile duct (CBD) injuries detected during laparoscopy, two injured gallbladders with with loss loss of calcul calculi, i, two viscer visceral al injuri injuries, es, and seven seven unspecified cases. The five CBD injuries were sutured through laparotomy with uneventful postoperative course, except in one patient who developed an external biliary fistula which resolved spontaneously. In 189 cases, the conversion was not motivated by a complication but by a ‘‘technical diffi-

58 Table 3. Circumstances of conversion

Cause



%

Technical difficulty Intraoperative complication CBD lithiasis Equipment failure Gallbladder tumor Not specified

189 43 34 8 1 45

59 13.4 10.6 2.5 0.3 14

culty.’’ This term refers to all the situations in which the laparoscopic route becomes inadequate—namely, difficult exposure, an inflamed gallbladder, or adhesions found in patients with previous laparotomy. Table 4 shows at which stage the operation was converted. Table 5 expresses the rate of conversion according to the clinic clinical al sympto symptoms ms and the patien patient’s t’s age. age. An analys analysis is through through logist logistica icall regres regressio sion n shows shows that that the main main factor factorss influen influencin cing g the conversion conversion risk are age and the clinical clinical sympto symptoms ms ( p < 0.01) 0.01).. On the the othe otherr hand hand,, the the degr degree ee of  obesity does not influence it: The conversion rate is 6.3% (216/3,404) when the BMI is less than 30 kg/m2 and 6.9% when the BMI is higher than or equal to 30 kg/m 2 (NS).

 Length of procedure

The length of the pneumoperitoneum in group I is shown in Fig. 2. It was 58.5 ± 37.6 min for a normal-looking gallbladder and was significantly longer in case of acute inflammation (77.1 ± 45.7 min) or sclero-atrophy (72.2 ± 45.1 min) of the gallbladder. The influence of obesity on the length of the procedure is almost insignificant in group I ( p 0.05).

 Intraoperative  Intraoperative cholangiography cholangiography (IOC)

Success rate. Intraopera Intraoperative tive cholangiog cholangiograph raphy y was attempted in 74.2% of the group I patients (2,838/3,821), and 33.4% of the group II patients (107/320). The success rate was 92.5% (2,627/2,838) in group I and 87.7% (93/107) in group II.

 Duration of IOC. In group I, the pneumoperitoneum lasted 53.4 ± 33.4 min when IOC was not attempted, 71.3 ± 44.2 min if the IOC was performed successfully ( p < 0.01), and 75.3 ± 41.4 min in case of failure of the IOC. The results of the IOC are shown in Table 6.

CBD surgery

CBD stones were demons demonstra trated ted by IOC in 217 patien patients. ts. There were 173 stone extractions from CBD by laparoscopy: 71 by a choledochotomy and 102 via the cystic duct using a Dormia basket. In 34 patients, the discovery of CBD calcul calculii led to convert convert into into laparot laparotomy. omy. Otherwi Otherwise, se, there there were eight negative choledochoscopies in group I and four attempts of a CBD repair (Table 7). In group I, the pneu-

moperitoneum lasted from 62 ± 38.32 min when no procedure was performed, to 113 ± 65.6 min when surgery was performed on the CBD ( p < 0.01).

Postoperative Postoperative complications complications

Complication rate. Some 230 postoperative complications were observed (overall morbidity: 4.9%)—203 in group I (4.7%) and 27 in group II (8.4%) ( p  p < 0.01).

Type of postoperative complications and conditions of occurrence (Table 8). The overall frequency frequency of postoperative postoperative complications in this series is 3.2% (87/2,698) for a normallookin looking g gallbl gallbladd adder, er, 4.8% 4.8% (19/39 (19/390) 0) in case case of sclero sclero-atrophic gallbladder, 8.8% (114/1,284) in case of acute inflammation, and 11.1% (13/117) in case of gangrenous cholecystitis. In group I the complication rate is 10% (10/99) when stones have spilled in the abdomen and 4.9% (100/  1,910) when no stones have been lost ( p < 0.01).

(Table 9). The symptoms symptoms of biliar biliary y  Biliary complications complications (Table complication were biloma ( N  16), one bile leak through the subhepatic drain ( N  15), symptoms of clinical and/or biological cholestasis ( N  12) intraabdominal abscess ( N  6), acute acute pancre pancreati atitis tis ( N  2) or biliar biliary y abnorm abnormali ality ty detected by postoperative cholangiography ( N  6). Three CBD injuries injuries were diagnosed diagnosed postoperat postoperativel ively y (0.06% (0.06%). ). One insta instance nce of sten stenosi osiss had to be reoper reoperat ated ed throug through h laparo laparotom tomy y after after failur failuree of treatm treatment ent by flexib flexible le endoscopy. In this patient, a lateral injury of the CBD had been detected at laparoscopy, and attempted repair through this approach had led to postoperative stenosis. The other two lesions were not detected during the initial procedure but were diagnosed postoperatively when jaundice ( N  1) or biloma ( N  1) appeared. All three cases had presented with acute cholecystitis; none of them had had an IOC. The residual stones were treated by endoscopic sphincterotomy (ES) in 20 patients. Fistula of the cystic stump was treated by laparotomy ( N  8), by laparoscopy ( N  5), or ES ( N  3). They resolved spontaneously in seven patients who had subhepatic drainage.

analysis Factors influencing postoperative morbidity. An analysis through logistical regression shows that age and a complicated form of biliary lithiasis increase significantly the risk  of postoperative complication ( p < 0.01) unlike the degree of obesity. The influence of the clinical symptoms on the type of  biliary complication is shown in Table 10.

 Mortality

Nine deaths were observed in this series (mortality: 0.2%). In three cases, death was a consequence of postoperative peritonitis due to one perforated ulcer at postoperative (PO) day day 3 and and two two visc viscer eral al inju injuri ries es whose whose loca locati tion on was was not not

59 Table 4. Stage of procedure at which the conversion was decided

Stage



Exposure Dissection of cystic duct Dissection of artery Intraoperative X-ray Freeing of gallbladder Exteriorization Not specified

116 55 14 30 29 11 65

Length of pneumop. (min)

Standard deviation (min)

25.2 59.8 67.8 67.5 61.6 107.2

32.5 40.1 44.2 37 40 43.7

Table 5. Conversion rate according to clinical symptoms and patient’s age

Age* Clinical symptoms*

Age <30

30 < age < 60

Age >60

Bile retention

9.3% (3/32) 5.8% (11/187) 1.4% (9/607)

17.6% (18/102) 13.6% (87/640) 3.4% (62/1805)

20% (12/60) 18.6% (61/328) 4.3% (19/435)

Acute cholecystitis Uncomplicated biliary colic

* p < 0.01

Table 6. Results of intraoperative cholangiography

Results

Group I

%

Group II

%

Normal Nonlithiasisc dilatation Lithiasis Not specified Failure Total

2170 264 176 30 205 3107

(69.8) (8.5) (5.6) (0.9) (6.5) 1

41 8 41 3 3 106

(35) (7.5) (38) (2.8) (12.2)

Table 7. Type of surgical procedure performed on the CBD in 231 group I patients

Type of surgical procedure



Choledocoscopy Choledochotomy Transcystic extraction Injury repair Not specified

 Length of hospital stay

8 71 102 4 46

The length of the hospital stay is shown in Table 11. Multivariate analysis shows that the conversion into laparotomy and postoperative complications are the main factors influencing the length of the hospital stay, unlike patient’s age and the clinical symptoms, whose influence is not significant.

Table 8. 230 postoperative complications

Intraabdominal complications Type Group II

%a

Group I

%a

Comments The aim of this study was to evaluate the results of laparoscopic cholecystectomy in 1994 among a large population of surgeons. With more than 150 surgeons participating and more than 4,600 patients included, it seems possible for this survey to achieve a number of conclusions, even if the results are made slightly imperfect by the very number of  surgeons involved. The methodology used does not allow one to know the number of classical cholecystectomies carried out in 1994; therefore, one does not know how the patients were selected for the laparoscopic approach. Moreover, the methodology does not allow one to know the

Intraabd. abscess Biliary* Parietal General complications Type

2 9 5

(0.6) (2.8) (1.5)

43 52 34

(1) (1.2) (0.7)

Group II

%a

Group I

%a

Cardiovascular Respiratory Thromboembolism Other Not specified

1 2 0 2 5

(0.3) (0.6) (0) (0.6) (1.5)

8 9 2 10 46

(0.01) (0.01) (0.01) (0.02) (1)

a

specified. One death occurred after biliary reoperation through laparotomy, during which a choledochoduodenal anastomosis was performed for CBD lithiasis which had been revealed by a leak from the cystic stump. One patient died of cerebral infarction at reoperation for unexplained fever. In this particular case, abdominal exploration through laparotomy did not reveal any intraabdominal lesion. In two cases, death was due to cardiovascular complication. Finally, in two cases, the causes of death were not stated. Mortality is 0.1% in group I and 0.6% in group II (NS). Mortality for nonbiliary intraabdominal complications is 6.6%, and 1.6% for biliary complications.

Biliary complications include CBD residual stones

60 Table 9. Biliary complications

Type

Group I

%*

Group II

%

Residual stone Cystic leak Abnormal duct CBD transsection CBD stenosis

27 22 1 2 0

(0.6) (0.5) (0.02) (0.04) (0)

2 4 0 0 1

(0.6) (1.2) (0) (0) (0.3)

previous experience in laparoscopic surgery of each participant. However, it is an important parameter for the conversion rate. The aim of this study was not to evaluate all the parameters involved in this technique, but to provide a sort of photograph of laparoscopic cholecystectomy as it is performed in France by a large number of surgeons with, obviously, a wide range of experience in laparoscopy. This survey suggests a great number of comments, but we have chosen to focus on conversion, on the importance of intraoperative cholangiography, and on postoperative complications.

Reverting to laparotomy is not enough to prevent postoperative complications: In this study, postoperative morbidity is significantly higher in group II (morbidity rate: 8.4%) than in group I (morbidity rate: 4.9%). Conversion is performed only in difficult situations, either immediately, in view of the anatomopathological condition of the gallbladder, or as a consequence of previous attempts at laparoscopic surgery. In fact, conversion into laparotomy is not performed under the same conditions as a normal open cholecystectomy, since it is only resorted to in the most difficult cases. It is therefore not surprising that the morbidity rate is higher in group II than in group I. The problem is to determine whether an attempt at laparoscopy does or does not increase the difficulty—and hence the risks—of a cholecystectomy which could have been performed easily and safely by laparotomy in the first instance. Within the group of  patients with a normal gallbladder ( N  2,698), the morbidity rate is not statistically different between the subgroup of patients who have been converted and those who have not: 3.5% (2/56) vs 3% (80/2,642). The absence of significant difference allows one to think that the initial laparoscopic stage did not entail additional morbidity.

Conversion into laparotomy

It is generally admitted that conversion is the ‘‘safety net’’ of laparoscopic surgery: The operator is indeed placed in a more classical situation, particularly in the case of intraoperative difficulties. The conversion rate is linked directly to the anatomopathological status of the gallbladder [21] and increases dramatically in case of acute infection such as acute or gangrenous cholecystitis. This is due to the fact that it is difficult to expose, grasp, and dissect the gallbladder whose wall is inflamed and thickened. In this series, age is associated with a significantly higher conversion rate, unlike obesity. The influence of these parameters on the conversion rate is variously appraised in other studies [11, 21, 22, 26]. Half of the conversions in this series were decided after a brief laparoscopic exploration of the abdominal cavity— mean duration 25 min. It is quite logical to first assess the feasibility and potential risks of a laparoscopic procedure and then revert to a more conventional approach if the feasibility of the laparoscopic approach is doubtful [13, 19, 20]. This approach, which does not discard complicated forms of  gallstone systematically, made it possible for 1,039 patients with a clinical picture of acute cholecystitis to enjoy the advantages of laparoscopy, since cholecystectomy was performed without conversion to laparotomy. But this is only possible if the operator is a trained surgeon who is able at any stage of the procedure to decide which approach is more appropriate. It is interesting to note that in this series, there is no stage beyond which the risk of conversion is nil, since 40 conversions were decided during the very last stages of  the procedure—namely, during freeing and exteriorization of the gallbladder. Converting to laparotomy means that all the advantages of laparoscopic surgery are lost, which can be seen, for instance, in the longer postoperative hospital stay [33]. It is absolutely necessary to inform the patient of  a possible conversion and to state figures, figures which can be calculated on the basis of the data collected in this survey (Table 5).

 Intraoperative cholangiography

What should be considered as a dogma—namely, systematic X-ray exploration of the CBD during cholecystectomy, regardless of the approach chosen—had not yet become routine in 1994, although it has been performed more and more frequently since the technique was first developed [4, 13, 36, 39]. Indeed, IOC was attempted in a little less than three cases out of four in group I and in one case out of three in group II. The exploration itself does not involve any special difficulty: Its mean duration is 20 min, with a success rate of 92.2%, which is similar to the results of other series [5–7]. IOC provided useful information in 15% of the cases: It allowed one to detect CBD lithiasis in 216 patients (6.7% of the tests carried out—213/3,213) and revealed signs of possible recent stone passage in 272 patients (8.4% of the tests performed). IOC is not only interesting to detect CBD stones; it also provides a detailed picture of the biliary tree and contributes to an early diagnosis of CBD injury [3, 23, 30, 35, 41]: of the three patients in this series who had undetected CBD injury, none had undergone IOC. Finally, the cost problem which is mentioned in American articles [3, 23] is obviously not relevant in France. All these elements together tend to speak in favor of wide use of the IOC, at least when the anatomy of the biliary tree is not obvious [16]. The frequency of postoperative complications depends in part on the anatomopathological condition of the gallbladder. This survey allows one to put into precise figures a well-known notion: the complication rate is 3.2% for a normal gallbladder, 4.8% in case of sclero-atrophic gallbladder, 8.8% in case of acute cholecystitis, and 11.1% in case of  gangrenous cholecystitis. These figures encourage not delaying surgery when symptomatic gallbladder lithiasis is found. In this series, biliary complications rank highest and represent approximately 25% of all postoperative compli-

61 Table 10. Influence of symptoms on the type of biliary complication

%

Clinical symptom

Residual stone

Leak through cystic stump

Leak through accessory duct

CBD injury

Biliary colic Cholecystitis Bile retention Pancreatitis

0.23 1.5 1.9 0.79

0.19 1.17 1.93 2.36

0.03 0 0 0

0 0.25 0 0

Table 11. Length of hospital stay according to conversion and postoperative complications

Cplca

Conversionb

 N 

Length of stay (days)

Standard deviation

p

No No Yes Yes

No Yes No Yes

4,058 293 203 27

4.5 13.1 9.5 16.6

2.7 10.7 4.6 11.2

<0.01 <0.01 <0.01 <0.01

a b

Cplc: Postoperative complication Conversion into laparotomy

Fig. 3. Evolution of results of laparoscopic cholecystectomy among SFCERO members.

cations. They include undetected CBD injuries, leaks through the cystic stump, and residual CBD lithiasis. The latter is not always a real complication insofar as a number of stones detected during the cholecystectomy are left behind on purpose, with a view to postoperative endoscopic sphincterotomy. This attitude may, however, result in reoperation through laparotomy in case of failure of the ES. It has been suggested that a transpapillary drain [10] be used in such circumstances in order to minimize the dangers and the risks of postoperative ES. Biliary fistula through the cystic stump represents the next most frequent biliary complication, it cured spontaneously in nearly one case out of  four (7/26) in patients who had a subhepatic drain. This therapeutic abstention is justified only when the IOC has proved the absence of calculi. Moreover, this result shows the importance of subhepatic drainage, particularly when the cystic stump is inflamed, as it minimizes the consequences of a possible bile leak. It seems that the peak time of undetected CBD injuries is now behind us [41]. Its rate in this study is 0.06%, which

is lower than the results found in most previous studies, where it averages 0%–0.4% [1, 3, 4, 8, 12–15, 17, 24, 27– 29, 31, 33, 36–39]. This evolution is probably due to better teaching/training and the surgeons’ increasing experience in laparoscopic surgery. When biliary complications arise, a morphological study including at least ERCP is absolutely necessary to assess the extent of the lesions precisely before considering an appropriate treatment [25, 35]. Seven cases of postoperative peritonitis were observed in this series. This complication seems to have had no link  whatsoever with the cholecystectomy itself in two cases: one perforated ulcer at PO day 3 and one appendicular peritonitis at PO day 35. On the other hand, for the three other patients, visceral damage occurred during cholecystectomy and remained initially undetected although the procedure was converted into laparotomy in two patients. This type of complication is particularly serious and actually caused the death of the patient in three cases (mortality: 42%). Visceral lesions may occur at various stages of the procedure: either during creation of the pneumoperitoneum, at insertion of the first trocar, or during the cholecystectomy, through mechanical or electrical damage to a neighboring hollow organ. One should remember that safety tests are essential during pneumoperitoneum creation, that open laparoscopy is particularly interesting in patients with abdominal scarring [9, 18, 34], that bipolar electrocoagulation is preferable, and that careful examination of the operative field at the end of the procedure is absolutely necessary. Finally, the presence of spilled stones in the abdominal cavity is associated in this series with a significant increase in postoperative morbidity (4.9% vs 10%). Although experimental studies have proved that intraabdominal stones are usually well tolerated [42], complete removal of lithiasis debris is necessary when the gallbladder is perforated inadvertently [32, 40, 42]. This is greatly facilitated by the use of an extracting bag to collect the calculi. Intraabdominal stone presence should not, however, lead automatically to conversion.

62 Table 12. Results of laparoscopic cholecystectomy in national multicenter studies

Country

Year

No. cases

No. surgeries

Conversions

Morbidity (%)

CBD injuries (%)

Mortality (%)

Europe (15) U.K. (38) France (36)a USA (1) France (12)b Espagne (39) Suisse (31) Italie (14) Francec

1991 1991 1992 1992 1993 1994 1994 1994 1995

1,236 1,518 3,606 1,771 2,955 2,342 3,722 6,865 4,624

20 59 119 23 41 69 179 59 150

3.6 4.7 7.1 4.6 4.8 5.1 7 3.1 6.9

1.6 5.1 4.3 6 3.4 7.1 4.8 2.5 5

0.3 0.5 0.3 0.2 0.6 0.4 0.6 0.2 0.06

0 0.07 0.05 0.05 0.2 0.12 0.08 0.06 0.2

a

SFCD register SFCERO register c Current study b

 Evolution of results since 1990

A similar study had been carried out in 1990 and 1991 by the SFCERO. A comparison of the results (Fig. 3) shows that mortality has not increased, but a slight increase in the morbidity rate and in the conversion rate can be observed. This is probably due on the one hand to the gradual extension of indications to complicated forms of biliary lithiasis and on the other hand to the growing popularity of the technique, which is no longer performed by experts only. The morbidity rate, in spite of a slight increase in its value, remains at an acceptable level, and similar to what is found in open cholecystectomy. Comparison with other national multicentre studies reveals that the results of laparoscopic cholecystectomy are quite similar from one country to the next (Table 12).

Conclusion The aim of this study was to obtain a snapshot of laparoscopic cholecystectomy as it was practiced in France in 1994 by surgeons with widely differing personal experiences. Two important notions appear: First of all, the fact that conversion into laparotomy does not guarantee that complications will not occur; on the contrary, the need to revert to laparotomy should make the surgeon aware of an increased risk of postoperative complication. It is not so much the conversion itself that should be avoided, but the circumstances that lead to it. Second, the best results in terms of conversion rate and postoperative morbidity are obtained in young patients with uncomplicated gallstones. The fact that laparoscopic surgery is more readily accepted by the patients allows an earlier indication of cholecystectomy, without having to wait for complications to occur. However, this notion should not encourage one to operate the asymptomatic gallstone. In addition, this work allows one to put into figures a number of notions that have long been known, such as the influence of the biliary symptoms on the procedure itself  and on the postoperative course. Lastly, this study confirms the good results obtained with laparoscopic cholecystectomy by a large community of  surgeons.

Participating surgeons Here are the names of the surgeons who have participated in this study: Andrieu, Baillet, Barbier, Barthe´le´my, Bauchu, Baumer, Beaujean, Becaud, Begin, Berger, Berlinski, Berthou, Bertin, Billard, Blais, Bloch, Bobois, Bosgiraud, Botella, Boudinet, Boulez, Bourgeois, Boustani, Boutami, Boyer, Breil, Brenner, Broutin, Caamano, Cabaniols, Callafe, Calvet, Cardin, Carlier, Cartalat, Cazagou, Chalbet, Chambon, Charbonneau, Charbonnier, Chastan, Chiche, Chigot, Churet, Claret, Collet, Cret, Cubertafond, Dartevelle, De Marliave, De Watteville, Debaert, Delassus, Delbecq, Denys, Derieux, Detruit, Dost, Dromer, Drouard, Dufilho, Durou, Elkhourge, Espalieu, Esso, Estienne, Faizon, Ferrier, Forest, Fourtanier, Frettigny, Gainant, Gandet, Garat, Garcia, Gehin, Gossot, Grandjean, Granier, Grousseau, Grumillier, Guinot, Guyon, Henry, Herve´, Hingrat, Hirigoyen, Horeau, Huten, Irles, Javaudin-Michelut, Jung, Kamouni, Keil, Kureeman, Laisne, Lambert, Lasnier, Le Goff, Le Scouarnec, Leconte-Perrin, Leger, Lequin, Leynaud, Luciani, Lupo, Maille, Mangin, Marchand, Massard, Mauras, Mazure, Meyer, Mondesert, Morel, Morvan, Mouret, Mourot, Mulliez, Pailler, Pe´rissat, Pernot, Peyredieu, Philippe, Poinsard, Priollet, Pugnet, Putnier, Rabinel, Retzaum, Richarme, Rivallain, Ros, Samama, Sarles, Sicard, Sirisier, Skawinski, Soler, Thomas, Timsit, Valla, Vankemmel, Vaujois, Vayre, Verecken, Vergos, Vernay, Viennois, Voitelier, Wojakowski.  Acknowledgment. We wish to express our heartfelt thanks to Dr. R. Salmi, MCU PH (Department of Biostatistics at the University of Bordeaux II, Prof. Salamon) for his kind help in the statistical treatment of the data collected in this study.

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Surg Endosc (1997) 11: 24–28

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Intraperitoneal adhesions in laparoscopic and standard open herniorrhaphy An experimental study R. Eller,1,2 R. Bukhari,1 E. Poulos,1 D. McIntire,4 E. Jenevein5 1

Department of General Surgery, St. Paul Medical Center, 5909 Harry Hines Boulevard, Dallas, TX 75235, USA Department of Surgery, Vanderbilt University Medical Center, Nashville, TN 37232-5732, USA 3 The University of Texas Medical Center at Dallas, 5223 Harry Hines Boulevard, Dallas, TX 75235, USA 4 Academic Computing Services, The University of Texas Medical Center at Dallas, 5223 Harry Hines Boulevard, Dallas, TX 75235-9066, USA 5 Department of Pathology, St. Paul Medical Center, 5909 Harry Hines Boulevard, Dallas, TX 75235, USA 2

Received: 8 April 1996/Accepted: 21 May 1996

Abstract.  Background: Intra-abdominal complications from transabdominal properitoneal (TAP) laparoscopic herniorrhaphy that would not be expected to occur in an open herniorrhaphy are possible. In a previous study, we reported the incidence of significant intra-abdominal adhesions from TAP herniorrhaphies using polypropylene in pigs.  Methods: To compare this with an open herniorrhaphy technique, we performed open herniorrhaphies on 31 pigs. Additional animals underwent TAP herniorrhaphy with PTFE. Data were collected on operative and trocar-site adhesions. Graft incorporation was recorded.  Results: No intra-abdominal adhesions were found in the 31 animals undergoing open herniorrhaphy. Fifteen adhesions were found in the 31 pigs that underwent TAP herniorrhaphy. These adhesions were graded and there were a total of  nine significant adhesions with the TAP procedure. A total of 124 trocar sites resulted in two adhesions. Laparoscopically placed polypropylene was better incorporated than PTFE. The laparoscopically placed PTFE grafts commonly were poorly incorporated. Conclusions: We conclude that there is a risk of intraabdominal adhesions to either the operative site or the trocar sites in TAP herniorrhaphy that is not present in open techniques. One should, therefore, be circumspect in the choice of TAP herniorrhaphy as a primary repair. Key words: Adhesions — Hernia — Laparoscopy — Prosthetic

Correspondence to: E. Poulos

Laparoscopic inguinal herniorrhaphy is a commonly performed procedure. Although its advantages compared with current open approaches are currently being debated, questions are still unanswered about the intraperitoneal effects of  laparoscopic inguinal herniorrhaphy. The authors are concerned that a transabdominal laparoscopic approach to inguinal herniorrhaphy incites more adhesion formation than does an open approach. In theory, intraperitoneal adhesions are infrequently seen following open inguinal herniorrhaphy. The hypothesis that transabdominal laparoscopic hernia repairs incite more significant adhesions than an open inguinal herniorrhaphy must be rejected if this technique is to become a universally acceptable option for all patients with inguinal hernias. Likewise, if laparoscopic inguinal herniorrhaphy is the appropriate choice for a particular patient, the prosthetic material used for the repair should be strong, nonabsorbable, and well incorporated, yet not contribute to adhesion formation. This experiment was designed to follow a previous study looking at adhesion formation after laparoscopic herniorrhaphy in a porcine model [4]. That study showed no adhesions to any of the laparoscopic port sites and a small number of significant adhesions to the laparoscopic repair site. The study did not address the question of the incidence of adhesion formation during open herniorrhaphy and used only one type of prosthetic material to perform the repairs. This expansion of the previous study was designed to examine the incidence of intraperitoneal adhesions after open herniorrhaphy and to examine differences in prosthetic materials used both in open and TAP laparoscopic inguinal herniorrhaphy. Laparoscopic port sites were monitored for adhesions, and overall performance of the prosthetic materials was evaluated. A porcine model was again chosen for the study because of the similarity of the anatomy to the

25

Fig. 2. Adhesions were graded by this scale adapted from numerous studies in the OB/GYN literature.

inguinal region in humans and because of their ease of  management during and between the procedures. Some differences do exist in the anatomy, but the similarities were the overriding consideration. This protocol was approved by the Institutional Animal Use Committee of St. Paul Medical Center in Dallas, Texas.

weeks. Their physical condition was excellent and their health was monitored by a veterinarian. The animals were returned to the operating room and given the same preoperative medications, except for the cefoxitin. They were anesthetized, intubated, and placed on the ventilator in the same manner as before. Since laparoscopy offers a clear, magnified view of the operative sites and the opportunity to examine the old trocar sites, the animals first underwent diagnostic laparoscopy through a left paramedian site. The operative sites and trocar sites were examined for adhesion formation, and all adhesions were graded by the adhesion classification shown in Fig. 2. The prosthetic graft was then examined for overall appearance and degree of reperitonealization. Additional ports were placed and the graft was dissected, removed, and sent for pathologic evaluation. At the conclusion of the laparoscopic procedure, a midline celiotomy was made and the peritoneal cavity was examined systematically. In accordance with the protocol, the animals were then euthanized with intracardiac thiopental sodium. All procedures were performed by the same team of investigators. All gross and microscopic studies were done by a single pathologist.

Materials and methods

Open patch herniorrhaphy

Fig. 1. Details of study design.

To evaluate the two different surgical approaches and the two different prosthetic materials, four groups of animals were studied. Group 1 underwent TAP herniorrhaphy with a polypropylene mesh prothesis. Group 2 underwent open herniorrhaphy with a polypropylene mesh prosthesis. Group 3 underwent TAP herniorrhaphy with an expanded PTFE prosthetic graft while group 4 underwent an open herniorrhaphy with an expanded PTFE prosthetic graft. Figure 1 shows the study design. All of the animals underwent diagnostic laparoscopy prior to their procedure to identify any anatomic variation or congenital adhesion. Our techniques for TAP and open herniorrhaphy are described below.

TAP laparoscopic herniorrhaphy Thirty-one animals with an average weight of 20 kg each received 8 mg/kg of ketamine and 0.2 mg of glycopyrrolate intramuscularly 5 min before induction of general anesthesia. Anesthetic gases for induction were delivered through a special snout mask devised from an ambu bag. General endotracheal anesthesia was induced in the animals, and they were then intubated with a standard 5 F endotracheal tube and maintained on a mixture of oxygen, nitrous oxide, enflurane, and isoflurane. A single dose of cefoxitin was administered intramuscularly prior to starting the operative procedure. The animals’ abdomens were then clipped, prepared, and draped sterilely. A Veress needle was percutaneously placed in the abdomen and the abdomen was insufflated with CO2 gas to 14 mm of Hg pressure. A three-port technique was utilized by placement of a right paramedian 10– 12-mm port for the laparoscope and right and left lateral 10–12-mm operating ports. In all animals the midline attachment of the bladder to the anterior abdominal wall was reflected to facilitate exposure. The pelvic anatomy was then dissected bilaterally and the peritoneum was incised over the inguinal region and reflected. The pubis, ileopubic tract, Cooper’s ligament, internal inguinal ring, inferior epigastric vessels, cord structures, and transverse abdominal arch were all identified. A dumbbell-shaped 31 ⁄ 2 × 5 cm piece of either polypropylene or PTFE was placed behind the inferior epigastric vessels on the left side and secured with staples. After placement of the graft, both sides were reperitonealized using the stapling instrument. Ports were then removed and the fascial defects were repaired, taking special care not to involve the peritoneum in the closure. The skin was then approximated with subcuticular sutures. The animals were then awakened, extubated, and returned to their pens after a brief period of observation. The animals were then cared for in a standard laboratory setting for 4–6

Thirty-one animals received the same preoperative medications and anesthetic protocol as was used for the previously described TAP herniorrhaphy procedure. The abdomen was the clipped, prepared, and draped in sterile fashion. A Veress needle was placed into the abdomen and the abdomen was insufflated with CO2 to 14 mmHg pressure. A right paramedian 10–12-mm port was then placed and a laparoscope was passed into the abdomen. The abdomen was examined for the presence of  de novo adhesion formation. Once this laparoscopic examination was complete, the abdomen was desufflated. A transverse incision was made over the left groin and carried down to the external oblique fascia sharply. The external oblique aponeurosis was incised and the cord structures were exposed. The cord structures were dissected and a prosthetic graft of either polypropylene or PTFE was then sutured in place. The abdomen was again insufflated and the operative area was examined with the laparoscope to insure that the peritoneum had not been violated. The laparoscope and the port were then removed and the fascial defect was closed as before. The external oblique aponeurosis was approximated with interrupted sutures and the skin was approximated with running subcuticular sutures. The animals were awakened, extubated, and returned to their pen after a brief period of observation. The animals were then cared for in a standard laboratory setting for 4–6 weeks. Their physical condition was excellent and their health was monitored by a veterinarian. The animals were then returned to the operating room and given the same preoperative medications, except for the cefoxitin. They were anesthetized, intubated, and placed on the ventilator in the same manner as before. As before, the animals first underwent diagnostic laparoscopy through a left paramedian site. The operative sites and port site were examined for adhesion formation and all adhesions were graded as before. The abdomen was then opened with a midline celiotomy and the peritoneal cavity was examined systematically. The prosthetic graft was then excised en bloc with the surrounding tissue and sent for pathologic evaluation. In accordance with the protocol, the animals were then euthanized with intracardiac thiopental sodium. All procedures were performed by the same team of investigators. All gross and microscopic studies were done by a single pathologist.

Results

The findings of the study broken down by group are as follows:

26 Table 1. Adhesions to the graft

Type of repair

n

Total adhesions to the graft

Laparoscopic, poly Open, poly Laparoscopic, PTFE Open, PTFE

21 10 10 21

12 0 3 0

Table 2. Adhesions to the sham site

Grade 1

Grade 2

Grade 3

Type of repair

5 0 1 0

5 0 1 0

2 0 1 0

Laparoscopic, poly Laparoscopic, PTFE

n

Total adhesions to the sham

Grade 1

Grade 2

Grade 3

21 10

3 2

3 1

0 0

0 1

Table 3. Adhesions to the trocar sites

Group I: TAP laparoscopic herniorrhaphy with  polypropylene mesh

Twenty-one animals were studied. Twelve animals formed adhesions to the prosthetic graft—7 of which were grade 2 or greater. Three animals formed grade 1 adhesions to the side of the sham dissection. The grafts were generally well incorporated with infrequent distortion. There was a total of  63 trocar sites with no adhesions formed in this group.

Group II: open herniorrhaphy with polypropylene mesh

Ten animals were studied. None of the animals formed adhesions to the operative site. The grafts were all well incorporated without distortion. There were a total of ten trocar sites followed; one grade 1 adhesion formed in this group.

Group III: TAP laparoscopic herniorrhaphy with PTFE 

Ten animals were studied. Three animals formed adhesions to the prosthetic graft—two of which were grade 2 or greater. Two animals formed adhesions to the sham side; one was grade 1 and the other was grade 3. The grafts were not as well incorporated as the polypropylene mesh and most of the grafts greatly distorted. There were 30 trocar sites followed; one grade 1 adhesion formed in this group.

Number of sites

Total adhesions

Grade 1

Grade 2

Grade 3

124

2

2

0

0

Table 4. Tap vs open

No. of animals Total adhesions Grades 2 & 3 Grade 3 only

Tap procedure

Open procedure

p value

31 15 9 3

31 0 0 0

6.46E-06 0.002 0.238

Table 5. Polypropylene vs. PTFE

No. of animals Total adhesions Grades 2 & 3 Grade 3 only

Polypropylene

PTFE

p value

21 12 7 2

10 3 2 1

0.016 0.677 1.0

difference between the polypropylene and the PTFE was detected.

Discussion Group IV: open herniorrhaphy with PTFE 

Twenty-one animals were studied. None of the animals formed adhesions to the operative site. The grafts were all well incorporated without distortion. There were a total of  21 trocar sites; no adhesions formed in this group. Tables 1–3 summarize the raw data on the adhesions identified, with each type of prosthetic material and operative technique, the adhesions found to our sham sites (internal control), and the adhesions found to the 124 port sites. A comparison of the adhesions formed in the TAP procedure and the adhesions formed during the open procedures without regard for the type of prosthetic material used in the repair revealed a highly significant difference between the two techniques. This is shown in Table 4. Table 5 shows a comparison of the two types of prosthetic materials studied during TAP laparoscopic herniorrhaphy. There was a significant difference between the two materials when all adhesions were considered. However, if  only grade 2 and grade 3 adhesions were considered, the difference in the number of adhesions found failed to reach significance. If grade 2 adhesions alone were considered, no

Intra-abdominal adhesions are now the most common cause of intestinal obstruction, and most of these adhesions are iatrogenic in origin [6, 8, 9, 20]. Current theories on adhesion formation involve the presence of ischemic or avascular tissue [6, 7, 9], including foreign bodies [3, 16, 18], and factors that decrease peritoneal proteolytic activity [15]. These observed elements, when present, lead to a fibroproliferative inflammatory reaction [1]. Many efforts directed at better defining and modulating this process are in progress. These studies have looked at different drugs and solutions either placed intraperitoneally or given systemically [12, 14, 19, 21], the effect of various endogenous cytokines [13]; they have also looked at the effect of different materials placed on the area of peritoneal injury, which are intended to block adhesion formation to that site or are used in performing the operative procedure [2, 5, 10, 11, 17]. These efforts have met with some promising results but have not cured the problem. The authors, as others, are concerned that TAP laparoscopic herniorrhaphy has the potential to incite intraabdominal adhesions at the site of the hernia repair and at the laparoscopic port sites. Since it has been assumed that

27

open herniorrhaphy techniques do not incite intraabdominal adhesion formation, it would need to be shown that the TAP procedure also did not incite adhesions. For the purposes of this study, it was not assumed that open repair was free of risk for inciting adhesions, and the hypothesis was set forth that the two procedures had an equal propensity to form intra-abdominal adhesions. The data presented here show clearly that this hypothesis is false. There is a significant difference between TAP laparoscopic herniorrhaphy and open herniorrhaphy when considering intra-abdominal adhesion formation. As shown in Table 4, even when grade 1 adhesions are not considered, there remains a highly significant difference in the number of adhesions formed. Due to the practical limitations on the number of animals that can be studied, it cannot be said, based on this study, that open herniorrhaphy never incites intra-abdominal adhesions. However, based on these data and using confidence intervals determined by the exact method of Mietenin, it can be said with 95% confidence that there is a 9.2% maximum risk of adhesion formation for the open hernia repair. Using this same method, as many as 48% of TAP laparoscopic herniorrhaphies may incite significant adhesions (grade 2 or greater) at the operative site. This study shows that TAP laparoscopic herniorrhaphy clearly incites more adhesions than the open procedure in this experimental model. A total of 124 trocar sites were followed through the study, with two adhesions identified. Both were grade 1 adhesions. This shows that port sites can be the source of  adhesions. A single adhesion from a trocar site to a loop of  the small bowel could serve as an axis for volvulus or could trap a knuckle of intestine and lead to strangulation or obstruction. Clearly, this must have a very low incidence; however, these data suggest that it should be considered in patients presenting with symptoms of bowel obstruction and a history of laparoscopic procedures. Since TAP laparoscopic herniorrhaphy has been demonstrated to be a cause of significant adhesions in this animal model, should this type of hernia repair be considered an option for patients with inguinal hernias? As all operations have certain risks and benefits associated with them, this finding alone should not be used to select one type of  hernia repair over another. Different patients with different clinical findings will need the best operation for their situation. A small increase in the incidence of adhesions might be acceptable in certain cases where an open approach had increased risk associated with it, such as a recurrent hernia. Also, if data were available showing a significant decrease in recurrence rates with a laparoscopic approach when compared with an open approach, a small increase in the incidence of adhesions might be acceptable in order to obtain the lower recurrence rate in both first-time repairs and in patients with recurrences. In these circumstances, a TAP laparoscopic herniorrhaphy would be an acceptable alternative. A comparison of prosthetic materials can be made based on these data as well. In the open procedure, both polypropylene and PTFE performed well with good incorporation of the graft and minimal distortion of the prosthetic material. However, the materials differed in their performance in the TAP laparoscopic procedure. There was a significant difference in the total number of adhesions incited by the

two materials, as illustrated in Table 5. When looking at the more severe adhesions only, the statistical significance drops off, and when comparing only grade 3 adhesions, there is no statistical difference. If one assumes that adhesions are more likely to form to less vascularized tissue and that polypropylene mesh is better and more rapidly incorporated, then one could postulate that the peritoneum replaced over the polypropylene would be more rapidly revascularized than the peritoneum replaced over the PTFE. This could account for the surprising finding of more lowgrade adhesions to the PTFE repairs. The gross appearance of the prosthetics at the end of the study was also noticeably different. Although no statistical evaluation techniques were applied to this aspect, it was obvious to the investigators that the PTFE grafts were markedly distorted and many were poorly incorporated.

Conclusions

We feel, based on the data presented, that the following conclusions can be supported: 1. TAP laparoscopic herniorrhaphy incites significant adhesion formation at the site of repair. 2. Laparoscopically placed polypropylene incited fewer adhesions and retained its configuration better than PTFE over the course of the study. 3. There was no difference between polypropylene and PTFE placed by an open technique. 4. Significant adhesions rarely form at port sites. 5. TAP laparoscopic herniorrhaphy appears to have a higher rate of intraperitoneal adhesion formation and one should be circumspect in its choice as a primary repair.  Acknowledgment. Special thanks to Mr. Roosevelt Yancey, who took excellent care of the animals as well as providing expert assistance during the procedures. Thanks also to Mrs. Kathy Tegtmeyer for her assistance in the preparation of this manuscript.

References 1. Ar’Rajab A, Dawidson I, Sentementes J, Sikes P, Harris R, Mileski W (1995) Enhancement of peritoneal macrophages reduces postoperative peritoneal adhesion formation. J Surg Res 58(3): 307–312 2. Azziz R, Murphy A, Rosenberg S, Patton G (1991) Use of an oxidized, regenerated cellulose absorbable adhesion barrier at laparoscopy. J Reprod Med 36: 479–482 3. Conolly WB, Stephens FO (1968) Factors influencing the incidence of  intraperitoneal adhesions: an experimental study. Surgery 63: 976–979 4. Eller R, Twaddell C, Poulos E, Jenevein E, McIntire D, Russell S (1994) Abdominal adhesions in laparoscopic hernia repair: an experimental study. Surg Endosc 8: 181–184 5. Elliot M, Juler G (1979) Comparison of Marlex mesh and microporous Teflon sheets when used for hernia repair in the experimental animal. Am J Surg 137: 342–344 6. Ellis H (1971) The cause and prevention of postoperative intraperitoneal adhesions. Surg Gynecol Obstet 133: 497–511 7. Ellis H (1978) Wound repair—reaction of the peritoneum to injury. Ann R Coll Surg 60: 219–221 8. Ellis H (1980) Internal overhealing: the problem of intraperitoneal adhesions. World J Surg 4: 303–306 9. Ellis H (1982) The causes and prevention of intestinal adhesions. Br J Surg 69: 241–243 10. Fitzgibbons RJ Jr, Salerno GM, Filipi CJ, Hunter WJ, Watson P (1994)

28

11.

12. 13.

14.

15.

A laparoscopic intraperitoneal onlay mesh technique for the repair of  an indirect inguinal hernia. Ann Surg 219(2): 144–156 Haney AF, Hesla J, Hurst BS, Kettel LM, Murphy AA, Rock JA, Rowe G, Schlaff WD (1995) Expanded polytetrafluoroethylene (GoreTex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Fertil Steril 63(5): 1021– 1026 Jansen R (1991) Prevention of pelvic peritoneal adhesions. Curr Opin Obstet Gynecol 3: 369–374 Kaidi AA, Gurchumelidze T, Nazzal M, Figert P, Vanterpool C, Silva Y (1995) Tumor necrosis factor-alpha: a marker for peritoneal adhesion formation. J Surg Res 58(5): 516–518 LeGrand EK, Rodgers KE, Girgis W, Campeau JD, Dizerega GS (1995) Comparative efficacy of nonsteroidal anti-inflammatory drugs and anti-thromboxane agents in a rabbit adhesion-prevention model. J Invest Surg 8(3): 187–194 Menzies D, Ellis H (1991) The role of plasminogen activator in adhesion prevention. Surg Gynecol Obstet 172: 362–366

16. O’Leary DP, Coakley JB (1992) The influence of suturing and sepsis in the development of postoperative peritoneal adhesions. Ann R Coll Surg Engl 74: 134–137 17. Pans A, Pierard GE (1992) A comparison of intraperitoneal prostheses for the repair of abdominal muscular wall defects in rats. Eur Surg Res 24: 54–60 18. Robbins GF, Brunschwig A, Foote FW (1949) Deperitonealization: clinical and experimental observations. Ann Surg 130: 466–479 19. Vipond MN, Whawell SA, Scott-Coombes DM, Thompson JN, Dudley HA (1994) Experimental adhesion prophylaxis with recombinant tissue plasminogen activator. Ann R Coll Surg Engl 76(6): 412–415 20. Weibel M-A, Majno G (1973) Peritoneal adhesions and their relation to abdominal surgery. A postmortem study. Am J Surg 126: 345–353 21. Wright JA, Sharpe-Timms KL (1995) Gonadotropin-releasing hormone agonist therapy reduces postoperative adhesion formation and reformation after adhesiolysis in rat models for adhesion formation and endometriosis. Fertil Steril 63(5): 1094–1100

Surg Endosc (1997) 11: 67–70

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Laparoscopic ultrasonography during laparoscopic cholecystectomy S. B. Kelly,1 D. Remedios,2 W. Y. Lau,1 A. K. C. Li1 1 2

Department of Surgery, Prince of Wales Hospital, Shatin, New Territories, Hong Kong Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

Received: 8 November 1995/Accepted: 5 May 1996

Abstract  Background: This study assessed the effectiveness of laparoscopic ultrasonography in demonstrating biliary anatomy, confirming suspected pathology, and detecting unsuspected pathology.  Methods: Laparoscopic ultrasonography was performed on 48 patients (17 M:31 M) who underwent laparoscopic cholecystectomy. An Aloka 7.5-MHz linear laparoscopic ultrasound transducer was used for scanning.  Results: Gallbladder stones were confirmed by laparoscopic ultrasonography in all patients and unsuspected pathology was found in five patients. Two patients were found to have common bile duct stones by laparoscopic ultrasonography and this was confirmed by laparoscopic cholangiography. Laparoscopic ultrasound was found to be helpful during dissection in four patients, particularly in a patient with Mirizzi syndrome. The entire common bile duct was visualized by laparoscopic ultrasonography in 40 patients but was poorly seen in eight patients. The mean time taken for the examination was 9 min (range 4–18 min). Conclusion: Laparoscopic ultrasound is useful during laparoscopic cholecystectomy. Key words: Laparoscopic ultrasonography — Laparoscopic cholecystectomy

Laparoscopic cholecystectomy has become widely accepted as the treatment of choice for symptomatic gallstones. Previously, intraoperative cholangiography was standard for examining the anatomy of the common bile duct (CBD), especially in detecting calculi. However, because laparoscopic cholangiography is more difficult to perform, it is no longer routine practice in our unit. Subsequently, there is an increased incidence of bile duct injuries. To avoid such complications, laparoscopic cholangiography with its attendant difficulties has been advocated in routine laparoscopic

Correspondence to: A. K. C. Li

cholecystectomy [1, 11]. However, laparoscopic ultrasonography may be an effective substitute for laparoscopic cholangiography [4, 12, 13]. Furthermore, when laparoscopic cholangiography fails, it may help to identify the biliary anatomy prior to dissection. By contrast, laparoscopic cholangiography cannot be performed prior to dissection of the cystic duct. The purpose of our study was to assess the effectiveness of laparoscopic ultrasonography in (1) demonstrating the biliary anatomy, (2) confirming suspected pathology, and (3) detecting unsuspected pathology.

Patients and methods The role of laparoscopic ultrasonography was assessed in 48 patients (17 M: 31 F) undergoing laparoscopic cholecystectomy, mean age 56 years (range 26–89 years). Preoperative transabdominal ultrasound was performed in all patients. ERCP was performed preoperatively in patients with evidence of ductal stones, ductal dilatation, or liver function tests which were suggestive of biliary obstruction. Patients with suspected CBD stones undergoing ERCP were included in the study group. An Aloka 7.5-MHz linear laparoscopic ultrasound transducer (model UST-5522L-7.5) (Fig. 1) was used for intraoperative scanning and this was connnected to a multipurpose Aloka echo camera (model SSD-650). Adhesions, if present, are dissected first to allow accurate placement of the transducer on the common bile duct. Biliary scanning is then performed prior to dissection of Calot’s triangle. The technique is as follows. The transducer is inserted through a disposable port in the right upper quadrant of the abdomen. A trocar with a metal valve should be avoided as it may damage the transducer. Scanning is performed in the following sequence. Both lobes of the liver are scanned by placing the transducer on its superior surface. The gallbladder is then scanned by placing the transducer directly on its inferior surface. The fundus of the gallbladder is grasped with toothed forceps and lifted up over the liver edge. Hartmann’s pouch and the cystic duct are then scanned. Following this, the transducer is placed under direct vision on the lateral aspect of the hepatoduodenal ligament with its scanning surface facing medially [2, 9, 12]. The CBD is located and its diameter is measured. The CBD should be kept continuously in the field of  view and it is scanned down to the papilla of Vater, where it can be seen to join the pancreatic duct. The ampulla is a difficult area to visualize. Two landmarks may help in its differentiation. The first is the junction of the CBD and pancreatic duct. The second is peristalsis in the duodenal wall when the duct can be seen to enter into an area of peristalsis. The transducer should be moved slowly, using a slight rotational motion which facilitates visualization of the three-dimensional structure of the elements being studied. This should be accompanied by a forward and backward movement of the transducer through the trocar. Air in the duodenum de-

68

Fig. 1. The Aloka 7.5-MHz ultrasound transducer which was used in this study.

grades the ultrasound image and this can be avoided by compressing the duodenum with the ultrasound transducer and aspirating air from the stomach and duodenum via a nasogastric tube. It is important not to compress the CBD with the transducer as this interferes with the detection of intraluminal stones and measurement of the CBD diameter. To facilitate the acoustic contact, warm saline solution can be instilled over the hepatoduodenal ligament. Furthermore, a better angle for the examination can be achieved by partial or complete reduction of the pneumoperitoneum. This was not required for any of the patients in this study. Finally, the common hepatic duct and the confluence of the right and left hepatic ducts are scanned. This may be performed by scanning from below the cystic duct or by dissecting Calot’s triangle and placing the transducer directly on the common hepatic duct, above the junction of the cystic duct and the CBD. If clips have been placed on either the cystic duct or cystic artery, they can degrade the quality of the image obtained. The right and left hepatic ducts can also be visualized by placing the transducer on the superior surface of  the liver and scanning through the liver parenchyma. The intrahepatic ducts are readily visualized by placing the transducer on the surface of the liver. With appropriate equipment, color Doppler imaging can be used to differentiate the CBD from the portal vein and the hepatic arteries [15].

Results Gallbladder stones were found in all patients and unsuspected pathology was found in five patients. Two patients were found to have common bile duct stones by laparoscopic ultrasonography and this was confirmed by laparoscopic cholangiography (Figs. 2, 3). The case of Fig. 3 has a very dilated biliary tree with complete obstruction to flow of  contrast into the duodenum. Preoperative liver function tests were normal. Preoperative ultrasound examination revealed a dilated CBD (8-mm diameter) but no intrahepatic duct dilatation. In the second case, preoperative liver function tests were also normal. ERCP was not performed preoperatively in either case. On preoperative transabdominal ultrasonography it was impossible to visualize the CBD, but there was no intrahepatic duct dilatation. Gallbladder carcinoma was suspected on preoperative ultrasonography in two patients. However, the appearances on laparoscopic ultrasonography were consistent with chronic cholecystitis, and this was confirmed by subsequent histological examination. Laparoscopic ultrasonography was found to be helpful during dissection in four patients, including one patient with Mirizzi syndrome in whom a laparoscopic subtotal cholecystectomy was only made possible with the help of lapa-

roscopic ultrasound [8]. This was technically difficult, but accurate identification of the biliary anatomy was made possible by laparoscopic ultrasound. Laparoscopic ultrasonography was found to be helpful in identifying the anatomy in two patients with multiple adhesions around the gallbladder, which was very inflamed and thickened and adherent to the liver. Preoperative ERCP was performed in seven patients. In five patients, a sphincterotomy was performed with removal of stones. Two patients had a normal ERCP. The entire CBD was visualized in 40 patients but was poorly seen in eight patients. The anatomical structures which were visualized are listed in Table 1. These structures were systematically searched for on laparoscopic ultrasound examination. The intrahepatic ducts could not be visualized properly in one patient because of liver cirrhosis and in another patient because of multiple liver cysts. One patient had multiple adhesions, which made it impossible to visualize the right lobe of the liver. The mean time taken for the examination was 9 min (range 4–18 min). Discussion Laparoscopic ultrasonography is a simple and reliable technique for imaging the biliary tract during laparoscopic cholecystectomy. It can be repeated at any stage during the operation and it does not require the use of contrast media or ionizing radiation. By performing contact biliary ultrasound, image degredation by the abdominal wall is overcome. It is possible to use a higher frequency (7.5-MHz) ultrasound transducer to achieve better image resolution, particularly in the near field. However, the higher frequency results in decreased penetration (approx. 8 cm for a 7.5MHz transducer). Laparoscopic biliary ultrasonography is now performed routinely for all laparoscopic cholecystectomies in our unit. Laparoscopic ultrasonography is associated with a relatively long learning period. Prior to this study, the authors had performed laparoscopic ultrasonography on 20 patients to ensure confidence in identifying the biliary ductal anatomy. Despite this, the percentage of arteries successfully visualized by laparoscopic ultrasonography was low (Table 1). This was due to inexperience of the operator and difficulty in visualizing the arteries. This could be improved by the use of Doppler ultrasonography. The sonographic anatomy of the hepatoduodenal ligament has been defined by Rothlin and Largiader [12]. Laparoscopic ultrasonography is performed prior to dissection and should be able to provide anatomical information to ensure safe dissection. This may help to prevent iatrogenic injury to the CBD. However, there were a few cases in this study in which it was not helpful. It is more difficult to interpret the images when inflammation or adhesions are present. The inability to interpret or visualize structures suggests the presence of anatomical or intraductal conditions which merit caution and demand confirmation by cholangiography. It can be difficult to visualize the upper end of the common hepatic duct and the hepatic confluence. These structures are scanned either with the transducer positioned below the cystic duct or by scanning through the liver with the transducer placed on the superior surface of  the liver. Once Calot’s triangle has been dissected it is possible to place the transducer directly onto the common hepatic duct. However, if clips have been placed on either the

69

Fig. 2. Sonographic view of stones at the lower end of the common bile duct. Fig. 3. Laparoscopic cholangiogram confirming the presence of stones at the lower end of the common bile duct.

Table 1. Anatomical structures visualised by laparoscopic ultrasonography

Structures visualised

Number

%

Gallbladder Cystic duct Common bile duct Common hepatic duct Right hepatic duct Left hepatic duct Intrahepatic ducts Pancreatic duct Right hepatic artery Common hepatic artery Left hepatic artery

48 34 40 40 27 23 43 18 26 17 1

100 71 83 83 56 48 90 38 54 35 2

cystic duct or artery, they can interfere with the quality of  the image obtained. The ampulla is also a difficult area to visualize. One method is to identify the junction of the CBD and pancreatic duct. The pancreatic duct was only visualized in 18 patients (38%) in this study. Ultrasonography during open surgery has been shown to facilitate intraoperative decision making [5, 6]. Previous studies comparing intracorporeal ultrasonographic evaluation of the bile ducts at open operation with operative cholangiography consistently demonstrated the equivalence or superiority of the ultrasound examination [2, 4, 9, 13]. Laparoscopic ultrasonography has been shown to be equal or superior to cholangiography for the detection of stones and may detect anatomical anomalies [12, 13, 15]. Very small stones in the CBD may be visualized by ultrasonography,

which are not visible on cholangiography [13]. Patients with suspected CBD stones who had a preoperative ERCP had no abnormality found on laparoscopic ultrasonography. Laparoscopic cholangiography is performed to prevent iatrogenic injury to the bile ducts and to recognize unsuspected ductal calculi during laparoscopic cholecystectomy. However, the cystic duct must be dissected first, before cholangiography is possible. By contrast, laparoscopic ultrasonography can be used before any dissection has taken place. Laparoscopic ultrasonography takes less time to perform than cholangiography. The entire examination takes approximately 10 min to perform. Manipulation of the transducer is occasionally difficult because the operator has to watch both the video monitor and the ultrasound image. This problem can be overcome by using a videomixer, which allows the operator to visualize both the ultrasound image and the laparoscopic image on one screen [13]. Laparoscopic ultrasonography has been shown to be of  value in the assessment of intraabdominal malignancy [3, 4, 7, 10, 14, 15]. The potential for ultrasonography during laparoscopic cholecystectomy is considerable. It is important for the surgeon to use this technique regularly in order to gain the necessary experience for interpretation of the images. Future developments include the use of flexible probes to facilitate scanning. In addition, it would be valuable to compare laparoscopic ultrasonography with laparoscopic cholangiography. We also plan to evaluate scanning via the umbilical access port as this might be an easier technique than scanning via the port in the right upper quadrant.

70

References 1. Berci G, Sackier JM, Paz-Partlow M (1991) Routine or selected intraoperative cholangiography during laparoscopic cholecystectomy? Am J Surg 161: 355–360 2. Bismuth H, Castaing D (1987) Operative ultrasound in biliary surgery. In: Bismuth H, Castaing D (eds) Operative ultrasound of the liver and biliary ducts. Springer-Verlag, New York, pp 59–86 3. Cuesta MA, Meijer S, Borgstein PJ, Sibinga Mulder L, Sikkenk AC (1993) Laparoscopic ultrasonography for hepatobiliary and pancreatic malignancy. Br J Surg 80: 1571–1574 4. Jakimowicz JJ (1993) Intraoperative ultrasonography during minimal access surgery. J R Coll Surg Edinb 38: 231–238 5. Jakimowicz JJ, Rutten H, Jurgens P, Carol EJ (1987) Comparison of  operative ultrasonography and radiography in screening of the common bile duct for calculi. World J Surg 11: 628–634 6. Jakimowicz JJ (1988) Intraoperative ultrasound-biliary disease. In: Blumgart LH (ed) Surgery of the liver and biliary tract. Churchill Livingstone, Edinburgh, pp 393–402 7. John TG, Garden OJ (1994) Laparoscopic ultrasonography: extending the scope of diagnostic laparoscopy. Br J Surg 81: 5–6

8. Meng WCS, Kwok SPY, Kelly SB, Lau WY, Li AKC (1995) Management of Mirizzi syndrome by laparoscopic cholecystectomy and laparoscopic ultrasonography. Br J Surg 82: 396 9. Miles WFA, Paterson-Brown S, Garden OJ (1992) Laparoscopic contact hepatic ultrasonography. Br J Surg 79: 419–420 10. Okita K, Kodama T, Oda M, Takemoto T (1984) Laparoscopic ultrasonography. Diagnosis of liver and pancreatic cancer. Scand J Gastroenterol 19(Suppl 94): 91–100 11. Phillips EH, Berci G, Carroll B, Daykhovsky L, Sackier J, Pax-Partlow M (1990) The importance of intraoperative cholangiography during laparoscopic cholecystectomy. Am J Surg 56: 792–795 12. Rothlin M, Largiader F (1994) The anatomy of the hepatoduodenal ligament in laparoscopic sonography. Surg Endosc 8: 173–180 13. Stiegmann GV, McIntyre RC, Pearlman NW (1994) Laparoscopic intracorporeal ultrasound. An alternative to cholangiography? Surg Endosc 8: 167–172 14. Windsor JA, Garden OJ (1993) Laparoscopic ultrasonography. Aust N Z J Surg 63: 1–2 15. Yamashita Y, Kurohiji T, Hayashi J, Kimitsuki H, Hiraki M, Kakegawa T (1993) Intraoperative ultrasonography during laparoscopic cholecystectomy. Surg Laparosc Endosc 3: 167–171

Surg Endosc (1997) 11: 15–18

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Laparoscopic surgery during pregnancy B. M. D. Lemaire, W. F. M. van Erp Department of Surgery, Deaconess Hospital, P.O. Box 90052, 5600 PD Eindhoven, The Netherlands Received: 26 September 1995/Accepted 3 May 1996

Abstract  Background: Laparoscopic surgery is known for its many advantages, but the use of this modality during pregnancy is still under discussion.  Methods: The subjects in this discussion are the unknown influence of the pneumoperitoneum and the fear of damaging the uterus while inserting the Veress needle and trocars. In a review of recent literature describing laparoscopic surgery during pregnancy, no complications were seen. We performed four laparoscopic appendectomies and three laparoscopic cholecystectomies between 12 and 33 weeks estimated gestational age (EGA).  Results: All pregnancies passed without complications and ended in at-term deliveries of healthy babies. Conclusions: The risks, precautions to avoid them, and the safety of laparoscopic surgery during pregnancy are discussed in the light of our experience and reports in recent literature. Key words: Laparoscopic appendectomy — Laparoscopic cholecystectomy — Pregnancy — Risks — Precautions

Today laparoscopic surgery has become a world-wide accepted modality and it has found its way to many applications. Its success lies in the quick recovery of the patient. That’s why, for example, the laparoscopic cholecystectomy has become first choice instead of the open cholecystectomy in gallbladder disease. Although this seems self-evident, there is still a group of patients to whom it isn’t: pregnant women. The most common nonobstetric general surgical procedures during pregnancy are the appendectomy and the cholecystectomy, both accessible to laparoscopic surgery. Many controversies over the use of laparoscopic surgery during pregnancy exist. It is known that abdominal surgery during pregnancy increases the risk of miscarriage or premature labor. Also, exposure of the fetus to potential toxic agents like anesthetics and analgesics can cause harm. Par-

Correspondence to: W. F. M. van Erp

ticular laparoscopic risks are the effects caused by the pneumoperitoneum and the insertion of the Veress needle and trocars. Despite these concerns, we ask ourselves whether there is sufficient evidence to support the opinion that laparoscopic surgery should be contraindicated during pregnancy. We present seven case reports here and a review of  relevant literature in an attempt to answer that question. Four times a laparoscopic appendectomy was carried out at 12, 16, 17, and 26 weeks estimated gestational age (EGA) and three times a laparoscopic cholecystectomy at 22, 32, and 33 weeks EGA. Patients and methods Technique of insertion Entry sites of the Veress needle and trocars for laparoscopic appendectomy: The Veress needle was inserted in the left upper quadrant. Depending on gestational age, the entry site was chosen more toward the left costal margin. CO2 was insufflated to establish a pneumoperitoneum of 12 mmHg. After that the Veress needle was replaced by a 10–11-mm disposable trocar for the laparoscope. After inspection of the abdominal cavity the subsequent trocars were inserted under direct visualization. At umbilical level on the right a 11-mm trocar and on the left a 5-mm trocar were inserted. Entry sites of the Veress needle and trocars for laparoscopic cholecystectomy: The Veress needle was inserted in the midclavicular line, about 3 cm under the right costal margin. With CO2 a pneumoperitoneum of 12 mmHg was created. In the midepigastrium a 10–11-mm disposable trocar was inserted for the laparoscope. After inspecting the abdominal cavity and making sure that there was enough room to proceed laparoscopically, under direct vision a 10-mm trocar was inserted in the anterior axillary line above the umbilical level. Another 10-mm trocar was inserted right from the upper midline, just above the umbilical level. In our latest case we used a Direct Vision Initial Port (the Opti-view by Ethicon, Cincinnati, USA) to enter the abdominal cavity. Without a pneumoperitoneum the Opti-view trocar was inserted under direct vision just under the right costal margin. After insertion a pneumoperitoneum of 12 mmHg was established and the procedure went on as described above.

Case reports (Table 1)

Case 1. A 26-year-old woman at 12 weeks EGA was admitted to the hospital complaining of abdominal pain in the right lower quadrant, nau-

16 Table 1. Summary of reported cases of laparoscopic appendectomy and cholecystectomy during pregnancy

Operation

Gestation

Technique

Operative time Tocolysis Antibiotics

Appendectomy Appendectomy Appendectomy Appendectomy Cholecystectomy Cholecystectomy Cholecystectomy

12 16 17 26 23 32 33

Veress Veress Veress Veress Veress Veress Opti-view௡

20 min. 25 min. 40 min. 50 min. 35 min. 35 min. 45 min.

wks wks wks wks wks wks wks

No No No Yes Yes Yes Yes

Yes Yes Yes Yes No No No

sea, and vomiting. Her temperature was 37.6°C. There were signs of an acute abdomen at McBurney’s point and a leucocyte count of 19,000 cells/ml. The gynecological examination was normal. A laparoscopic appendectomy was carried out. There were no complications. At 37 weeks’ EGA she spontaneously delivered a healthy daughter.

Case 2. A 32-year-old woman presented in the 16th week of her pregnancy. She had acute pain at McBurney’s point and a temperature of  37.6°C. There was no leucocytosis. In agreement with her gynecologist a laparoscopy was performed. She was diagnosed as having an appendicitis, so a laparoscopic appendectomy was carried out simultaneously. At 22 weeks’ EGA premature contractions started. After receiving tocolytica the remainder of the pregnancy was without complications. At term the patient spontaneously delivered a healthy daughter.

Case 3. A 29-year-old woman, at 17 weeks’ EGA, had a history of 4 days of abdominal pain, mainly in the right lower quadrant. She had nausea and vomited. Her temperature was 37.8°C and there were signs of an acute abdomen at McBurney’s point. She had a leucocytosis of 17,000 cells/ml. On these findings a laparoscopic appendectomy was carried out. Her pregnancy was uneventful and at term she spontaneously delivered a healthy son.

Case 7. A 34-year-old woman, 33 weeks’ EGA, was referred to our department by her gynecologist after she had been observed under the suspicion of developing HELLP syndrome. She turned out to have symptomatic cholelithiasis, which did not respond to conservative treatment. She had to undergo a cholecystectomy. Despite her time of pregnancy we decided to start with a laparoscopic approach. There turned out to be enough working space in the abdominal cavity, so a laparoscopic cholecystectomy was carried out. Recovery of the patient was quick and without complications. Six weeks after surgery she spontaneously delivered a healthy son.

Perioperative management  In all cases before and immediately after the operation and after 24 h an ultrasound examination and/or CTG took place to check on the fetus. All showed normal fetal activity. The patients in cases 1, 2, 3, and 4 received prophylactic antibiotic therapy for 24 h and the patients of case 4, 5, 6, and 7 received prophylactic tocolithic therapy. Perioperatively all patients received 5,000 E heparin s.c. twice a day, starting 2 h before surgery until they were fully mobilised. The longest operation lasted 50 min, with a mean of 35 min. All patients were discharged from the hospital within 6 days after surgery.

Discussion Case 4. A 38-year-old woman in the 26th week of her third pregnancy was admitted to the hospital with abdominal pain in the right lower quadrant since day 1 of pregnancy. She had a temperature of 37.7°C and signs of  local peritonitis at McBurney’s point. She had a leucocyte count of 11,800 cells/ml. The gynecological examination was normal. As the signs of local peritonitis were so obvious, we decided to carry out a laparoscopic appendectomy, suspecting acute appendicitis. There were no further incidents during the remainder of her pregnancy and at term she spontaneously delivered a healthy son.

Case 5. A 22-year-old woman, in the 23rd week of her pregnancy, presented with colicky pain in the right upper quadrant of her abdomen. She had no other complaints and no fever. Her pregnancy was uneventful until then. There was local tenderness under the right costal margin. An ultrasound examination showed many concrements in the gallbladder. She had a leucocyte count of 16,700 cells/ml. Because she didn’t appear to be ill, she was dismissed from the hospital with a diet and butylscopolaminebromide. Unfortunately, 2 days later we had to carry out a laparoscopic cholecystectomy because of persisting colicks and progressing pain, despite conservative treatment. There were no complications after surgery. At term she spontaneously delivered a healthy son.

Case 6. A 26-year-old woman, 32 weeks’ EGA, was referred to our department by her gynecologist because of gallstone colicks. An ultrasound examination showed a hydropic gallbladder containing stones. She had no fever. Despite conservative management the pain became unbearable. Although she was already in the 32nd week of her pregnancy, we decided to carry out a laparoscopic cholecystectomy. The patient recovered quickly and spontaneously delivered a healthy girl at term.

Regarding laparoscopic appendectomy: The treatment for acute appendicitis is appendectomy. Randomized prospective trials in nonpregnant patients suggest that laparoscopic appendectomy for acute appendicitis significantly shortens hospital stay, reduces postoperative pain and discomfort, and speeds recovery [2]. Similar outcomes might be expected in pregnant women. Up till now there have been no similar studies in pregnant women; only a few case reports (13 reports) have been published. These laparoscopic appendectomies were carried out between 4 and 32 weeks EGA [5, 16, 17]. There were no abortions or premature deliveries. Diagnosing acute appendicitis in pregnancy can be very difficult. Symptoms and signs of appendicitis, like abdominal pain, nausea, vomiting, subfebril temperature and slightly elevated leucocyte count, are similar to common signs of pregnancy as well to those of gynecologic pathology such as ovarian cysts, adnexal torsion, etc., which can complicate pregnancy. The concerns about an exploratory laparotomy during pregnancy can lead to delay, with resultant perforation before surgery is done. Perforation occurs quicker in pregnancy and can have a fatal end with loss of the fetus and the mother as well. Persistence of symptoms and the fear of a fatal outcome result in a higher rate of negative appendectomies (35–55%, compared with 5–10% in nonpregnant

17

women) [9]. Diagnostic laparoscopy, with laparoscopic appendectomy when indicated, has the potential to improve both the above outcomes. In ongoing pregnancy the appendix can move upward to the right upper quadrant [9]. This also can hamper diagnosis and make it difficult to plan where to place the incision for appendectomy. This problem has no meaning in laparoscopy. Regarding laparoscopic cholecystectomy: The preferred treatment of acute cholecystitis and cholelithiasis in pregnancy is medical. Only in cases of failed medical treatment with recurrent bouts of cholecystitis, severe colics, jaundice, or pancreatitis is surgery recommended. In the literature, 26 reports of laparoscopic cholecystectomy have been described, carried out between 6 and 31 weeks EGA [1, 3, 4, 6, 7, 12, 14, 15, 18–20]. All pregnancies were uncomplicated. There are many different opinions about the indication to perform laparoscopic surgery during pregnancy. It is known that abdominal surgery during pregnancy has an increased risk of miscarriage or premature labor and if possible should be avoided. Some authors suggest that laparoscopic techniques may diminish this risk. Theoretically the panoramic view of the scope reduces the need for intraoperative uterine manipulation and thus results in less uterine irritability. This might decrease the incidence of postoperative fetal loss [13]. Hunter describes the use of laparoscopy for the diagnosis and treatment of ectopic pregnancy. In 20% of the cases the diagnosis was wrong and a uterine pregnancy was found. This group of patients had no greater fetal loss rate than is normal for this time of pregnancy [10]. One of the major concerns of laparoscopic surgery during pregnancy is the risk of damaging the gravid uterus. Especially in the second half of pregnancy there is a chance of injuring the uterus while inserting the Veress needle and trocars. Schreiber reports, while carrying out a laparoscopic appendectomy, injuring the uterine wall with the mandrel of  the 5-mm trocar during introduction. There was loss of a little amniotic fluid, but there was no severe bleeding. The remainder of the pregnancy was without complications [16]. A complication like this can be avoided by choosing an alternative entry site for the Veress needle [3]. In the first trimester the usual umbilical entry site can be used. In later pregnancy one should use an entry site far away from the uterus. Insertion in the left or right upper quadrant, midclavicular, about 3 cm below the costal margin would be appropriate. The following trocars can be brought in under direct vision. The puncture site is dependent on the organ to be operated on and the gestational age. This technique is also utilized in our cases and is mentioned under Technique of Insertion. Some authors recommended the open, Hasson technique [4, 6–8, 13–15]. Recently the so-called Direct Vision Initial Ports (like the Opti-view, by Ethicon, Cincinnati, OH, USA, and the Visiport, by U.S. Surgical, Norwalk, CT, USA) have become available. They can be used with or without pneumoperitoneum. These kinds of trocars are introduced under direct vision. We used the Opti-view trocar without pneumoperitoneum in the last case with satisfaction (see Technique of Insertion). There are also many questions about the influence of the pneumoperitoneum. Do increased intraabdominal pressure and CO2 absorption affect the fetus? No real analytic studies on humans have been published. All are observational in

nature, but until now no complications have been published. Hunter et al. experimented on pregnant sheep [11]. He investigated the influence of the increased intraabdominal pressure and CO2 absorption on the acid–base status, blood pressure, and heart rate of the ewe and the fetus. Creating a pneumoperitoneum with CO2 to 15 mmHg, a drop in pH into acidemic range in the mother and parallel to it in the fetus is seen. After 30 min a steady state is reached. Hyperventilating the mother brings the pH of both back to normal ranges. There were no changes in PaO2. There also were some hemodynamic effects: The mean fetal heart rate increased to 20 beats/min. The mean fetal arterial pressure increased to 10–15 mmHg. After desufflation pH, heart rate, and blood pressure turned to normal. Hunter et al. also used nitrous oxide as insufflating gas. Under the same conditions there were no effects on fetal blood-gas values, heart rate, and blood pressure. This indicates that fetal tachycardia and hypertension are caused by hypercarbia and not by increased intraabdominal pressure. Hunter et al. concluded that the pneumoperitoneum does not appear to create significant risk to the healthy fetus [11]. Other authors, too, have assumed that an intraabdominal pressure of 15 mmHg or less has no risks. The intrauterine pressure during contractions of the uterus and coughing is much higher [1, 4, 10, 14, 15, 18]. Following this advice, we choose to establish a pneumoperitoneum of 12 mmHg: low enough to be in the safe range, high enough to gain adequate visualization for safe procedural technique. Laparoscopy has several advantages compared with laparotomy. It is less invasive and it reduces the length of  hospitalization. There is less chance of incisional herniation, especially when the patient needs surgery during the latter stages of pregnancy [6, 7, 14]. Because there is less postoperative pain, there is less analgesic demand. This decreases the exposure of the fetus to potential toxic agents [3, 6, 7, 13, 14]. Pregnant women already have a higher risks of  thromboembolic complications. Rapid mobilization after laparoscopy reduces this risk after surgery [6, 7, 13, 14]. Intraoperative prophylaxis should be taken care of by administering heparin, 5,000 E s.c. twice a day, starting 2 h before surgery until the patient is fully mobilized. Also, depending on the size of the uterus, the patient should be put in Trendelenburg and left anterior oblique position to displace the uterus from the inferior vena cava. The use of  stockings also tends to avoid this complication. In our cases as well as in all of those previously reported, the outcome of pregnancy was not influenced by the laparoscopic surgical procedure. Thus these experiences minimize possible fetal complications arising from this technique. With the available data, laparoscopic surgery during pregnancy appears to be a safe and justified procedure.

References 1. Arvidsson D, Gerdin E (1991) Laparoscopic cholecystectomy during pregnancy. Surg Laparosc Endosc 3: 193–194 2. Attwood SEA, Hill ADK, Murphy PG, Thornton J, Stephens RB (1992) A prospective randomized trial of laparoscopic versus open appendectomy. Surgery 112: 497–501 3. Chandra M, Shapiro SJ, Gordon LA (1994) Laparoscopic cholecys-

18

4. 5.

6. 7.

8. 9. 10. 11.

12.

tectomy in the first trimester of pregnancy. Surg Laparosc Endosc 4: 68–69 Comitalo JB, Lynch D (1994) Laparoscopic cholecystectomy in the pregnant patient. Surg Laparosc Endosc 4: 268–271 Dressler F, Zo¨ckler R, Raatz D, Bo¨rner P (1992) Die Endoskopische Appendektomie in Gyna¨kologie und Geburtshilfe. Geburtshilfe Frauenheilkd 52: 51–55 Edelman DS (1994) Alternative laparoscopic technique for cholecystectomy during pregnancy. Surg Endosc 8: 794–796 Hart RO, Tamadon A, Fitzgibbons RJ, Fleming A (1993) Open laparoscopic cholecystectomy in pregnancy. Surg Laparosc Endosc 3: 13– 16 Hasson HM (1971) A modified instrument and method for laparoscopy. Am J Obstet Gynecol 6: 886–887 Heidenreich W (1983) Appendizitis und Schwangerschaft. Med Klin 78: 722–725 Hunter JG (1992) Discussion. Surg Endosc 6: 52–53 Hunter JG, Swanstrom L, Thormburg (1995) Carbon dioxide pneumoperitoneum induces fetal acidosis in a pregnant ewe model. Surg Endosc 9: 272–279 Morrell DG, Mullins JR, Harrison PB (1992) Laparoscopic cholecys-

13. 14.

15. 16. 17. 18.

19. 20.

tectomy during pregnancy in symptomatic patients. Surgery 112: 856– 859 Nezhat F, Nezhat C, Silfen SL, Fehnel SH (1991) Laparoscopic ovarian cystectomy during pregnancy. J Laparoendosc Surg 1:161–164 Pucci RO, Seed RW (1991) Case report of laparoscopic cholecystectomy in the third trimester of pregnancy. Am J Obstet Gynecol 165: 401–402 Schorr RT (1993) Clinical correspondence. Laparoscopic cholecystectomy and pregnancy. J Laparoendosc Surg 3: 291–293 Schreiber JH (1994) Results of outpatient laparoscopic appendectomy in women. Endoscopy 26: 292–298 Schreiber JH (1990) Laparoscopic appendectomy in pregnancy. Surg Endosc 4: 100–102 Shaked G, Twena M, Charuzi I (1994) Laparoscopic cholecystectomy for empyema of gallbladder during pregnancy. Surg Laparosc Endosc 4: 65–67 Soper NJ, Hunter JG, Petrie RH (1992) Laparoscopic cholecystectomy during pregnancy. Surg Endosc 6: 115–117 Wilson RB, McKenzie RJ, Fisher JW (1994) Laparoscopic cholecystectomy in pregnancy: two case reports. Aust N Z J Surg 64: 647–649

Surgical Endoscopy

Case reports Surg Endosc (1997) 11: 71–73

© Springer-Verlag New York Inc. 1997

Splenic rupture from colonoscopy A report of two cases and review of the literature E. A. Espinal, T. Hoak, J. A. Porter, F. A. Slezak Northeastern Ohio Universities College of Medicine, 4209 State Route 44, Rootstown, OH 44272, USA, and Department of Surgery, Summa Health System, Akron City Hospital, 525 East Market Street, Akron, OH 44309, USA Received: 21 September 1995/Accepted: 11 November 1995

Abstract. Splenic injury after colonoscopy is rare. Only 15 cases previously have been reported in the English literature. Partial capsular avulsion is the proposed mechanism of  injury. Any condition causing increased splenocolic adhesions may be a predisposing factor to splenic injury. Two cases of splenic injury following colonoscopy are reported in addition to a complete review of the literature. Key words: Colonoscopy — Complication — Splenic in jury — Splenic hematoma

Fiberoptic colonoscopy, in use since the early 1970s, is considered a safe procedure with relatively few complications [15]. Hemorrhage is the most common complication, with an incidence of 1–2%, and is most frequently associated with polypectomy [5, 9, 15]. Perforation is next most common, with an incidence of 0.1–0.2% [15, 16]. Other less-frequent and unusual complications have included pneumothorax, septicemia, mesenteric tears, colonic volvulus, and methane and hydrogen explosions [2, 9, 10, 15]. Solid visceral injuries have also been described. We present two cases of splenic injury from colonoscopy and a complete review of the literature.

Case report Case 1 A 57-year-old healthy woman underwent a sigmoid resection 5 years ago for focal diverticulitis and residual intramucosal carcinoma at a site of  polypectomy. At recent colonoscopy for surveillance, a small polyp 10 cm from the anus was removed. The lesion was snared without difficulty and the remainder of the colon was visualized to the ileocecal valve. There

Correspondence to: F. A. Slezak, 55 Arch Street, Suite 3D, Akron, OH 44304, USA

were no apparent technical difficulties. She was observed in the recovery area for 2 h and then discharged home. Ten hours following the procedure, the patient returned to the emergency department complaining of generalized abdominal pain. Her white blood cell (WBC) count was 8,500/mm3 and her hemoglobin was 14.7 g/dl. Her abdominal pain was felt to be due to air insufflated at colonoscopy and she was discharged home by the emergency department physician on bisacodyl and ketorolac. The patient returned to the emergency department 30 h following the procedure with severe abdominal pain in the left upper quadrant. Her vital signs were stable though she was diaphoretic. She had tenderness to palpation in the left upper quadrant without peritoneal signs. Her WBC was 9,200/mm3 and the hemoglobin was 11.0 g/dl. Her abdominal X-ray demonstrated no free air and a nonspecific bowel gas pattern (Fig. 1). After admission to the hospital, the pain worsened and a repeat hemoglobin was 9.0 g/dl. A computerized tomogram of the abdomen demonstrated a fractured spleen and hemoperitoneum (Fig. 2). When the patient became hemodynamically unstable, an urgent laparotomy was performed, which demonstrated dense adhesions around the spleen. The spleen had multiple capsular tears and was attached only at the hilum. A splenectomy was performed without difficulty. The patient recovered uneventfully and was discharged home on postoperative day 4. There was no intrinsic splenic disease on pathologic examination.

Case 2 A 60-year-old woman underwent diagnostic colonoscopy for evaluation of  rectal bleeding. She had undergone colonoscopic polypectomy 1 year prior to this procedure. She had a hysterectomy several years earlier through a Pfannenstiel incision. The procedure was uncomplicated and the entire colon was visualized without difficulty. Eight hours later, the patient presented to the emergency department with complaints of left shoulder and abdominal pain. The patient had a pulse of 80 and was not hypotensive. Her abdomen was diffusely tender with guarding. Her hemoglobin had fallen from 12.9 g/dl prior to the procedure to 10.4 g/dl. As the pain worsened in severity, a CT scan was obtained which demonstrated an intrasplenic hematoma and free intraperitoneal blood (Fig. 3). Following the CT scan, the patient became hemodynamically unstable and underwent urgent laparotomy. Approximately 1,000 cc of clot was evacuated from the abdomen. There was a large hematoma overlying the surface of the spleen with complete disruption of the splenic capsule. A splenectomy was performed and the patient had an uncomplicated recovery. The spleen was pathologically unremarkable for intrinsic disease.

72

Fig. 2. CT scan showing splenic hematoma marked by (+). Fig. 1. Abdominal roentgenogram obtained 30 h following colonoscopy showing a nonspecific bowel-gas pattern without free air.

Fig. 3. CT scan showing free blood  within the peritoneal cavity marked by (+).

Discussion

of the patients had a documented history of prior surgery and one patient had inflammatory bowel disease. Other purported contributing factors have included certain techniques used to navigate the splenic flexure such as the ‘‘slide-by’’ blind advancement of the endoscope past this region and ‘‘hooking’’ the splenic flexure to straighten the left colon [3, 14]. However, many splenic injuries have occurred in reportedly ‘‘easy’’ colonoscopies in patients without significant adhesions. The clinical signs and symptoms of  splenic injury include excessive abdominal pain in the left upper quadrant radiating to the left shoulder, tachycardia, and a drop in hemoglobin. Only one patient was asymptomatic. The incidence of such injuries may be higher than suggested by the literature, as many authors are not eager to publicize their morbidity [16]. One author stated that he was aware of ‘‘several unpublished cases’’ of splenic injury from colonoscopy [6]. In addition, splenic injury has been reported following endoscopic retrograde cholangiopancreatography [8]. These factors point to a higher incidence of endoscopic splenic injury than was once thought. Since colonoscopic splenic injury can be fatal, the complication should be suspected in patients who present with excessive abdominal pain or hypotension following colonoscopy in the absence of radiographic signs of perforation. CT scan appears to be the diagnostic modality of choice in the stable patient [17]. Not all splenic injuries require sple-

Splenic injury from colonoscopy is considered an exceedingly rare event. Including the two cases presented here, there are a total of 17 formally published case reports of this complication [1–7, 11–14, 17–19]. A review of these cases (Table 1) reveals an age range of 33 to 90 years, merely reflecting the population undergoing colonoscopy. Females outnumbered males 2.4:1. All but three patients were symptomatic from the injury within 24 h; however, fewer than half were diagnosed within 24 h. Eight patients were diagnosed by CT scan, six by laparotomy, and one each by angiography, ultrasound, and autopsy. Four of the 17 cases were successfully managed nonoperatively and were all patients in whom the diagnosis had been delayed. Those managed operatively all underwent splenectomy. There were two deaths, both in elderly males with renal failure and multiple other medical problems. Eight patients had colonoscopy with polypectomy performed, eight had diagnostic colonoscopy alone, and one had colonoscopy with esophagogastroduodenoscopy. It is the consensus of the reports that partial capsular avulsion is the main mechanism of injury and that anything causing increased splenocolic adhesions may be a predisposing factor to splenic injury. Cited examples have included prior abdominal surgery, inflammatory bowel disease, and pancreatitis [3, 6, 7, 14, 15]. In the literature, four

73 Table 1. Splenic rupture from colonoscopy: review of the literaturea

Year

Author

Proc

Diagnosis

Onset of SX

Delay in DX

Prior surg

Treatment

Outcome

1977 1979 1986

Telmos and Mittal Ellis and Harrison Castelli Reynolds and Moss Doctor and Monteleme Lerone and Wetzel Tuso and McElligott Gores and Simso Taylor and Frankl Merchent and Chang Rockey and Weber Rockey and Weber Colarian and Alousi Org et al. Espinal et al. Espinal et al. Heath and Rogers

C C C C C/P C/P C C/P C C C C/EGD C/P C/P C C/P C/P

Angio Lap Lap Lap Lap CT Lap Lap CT CT CT CT Autopsy US CT CT CT

<24 h 4h 24 h 14 h Never 6h <24 h 6h <6 h 2.5 days <1 day 6h 8h <24 h 8h 8h 36 h

3 days 3 days 1.5 days <1 day <1 day 1 day <1 day <1 day 10 days 5 days 8 days 36 h N/A 6 days 34 h <24 h 6 days

Unknown Unknown Unknown Unknown Unknown Yes No No Yes No Unknown Yes No Unknown Yes No Unknown

Splenectomy Splenectomy Splenectomy Splenectomy Splenectomy Splenectomy Splenectomy Splenectomy Transfusion Splenectomy Observation Transfusion ACLS Splenectomy Splenectomy Splenectomy Transfusion

Uncompl Uncompl Uncompl Dead Uncompl Uncompl Uncompl Uncompl Uncompl Uncompl Uncompl Uncompl Dead Uncompl Uncompl Uncompl Uncompl

1987

1989 1990

1991 1994

a

C colonoscopy, P polypectomy, EGD esophagogastroduodenoscopy, Angio scan, ACLS advanced cardiac life support, Uncompl uncomplicated.

nectomy; observation or splenorrhaphy may be options in selected cases. Management of these splenic injuries should be in accord with currently accepted surgical principles.

References 1. Castelli M (1986) Splenic rupture: an unusual late complication of  colonoscopy. Can Med Assoc J 134: 916–917 2. Colarian J, Alousi M (1991) Splenic trauma during colonoscopy. Endoscopy 23: 48–49 3. Doctor NM, Monteleme F (1987) Splenic injury as a complication of  colonoscopy and polypectomy: report of a case and review of the literature. Dis Colon Rectum 30: 967–968 4. Ellis WR, Harrison JM (1979) Rupture of spleen at colonoscopy. Br Med J 1: 307–308 5. Gores PF, Simso LA (1989) Splenic injury during colonoscopy. Arch Surg 124: 1342 6. Heath B, Rogers A (1994) Splenic rupture: an unusual complication of  colonoscopy. Am J Gastroenterol 89: 449–450 7. Lerone E, Wetzel LH (1987) Splenic trauma during colonoscopy. Am J Roentgenol 149: 939–940 8. Lo A (1994) Splenic trauma following endoscopic retrograde cholangiopancreatography. Surg Endosc 8: 692–693

angiography, Lap

laparotomy, US

ultrasound, CT

CT

9. Machae FA, Tan KG (1983) Towards safer colonoscopy: a report on the complications of 5,000 diagnostic or therapeutic colonoscopies. Gut 24: 376–383 10. Marino AW (1978) Complications of colonoscopy. Dis Colon Rectum 21: 1–19 11. Merchant AA, Chang EH (1990) Delayed splenic rupture after colonoscopy. Am J Gastroenterol 85: 906–907 12. Org E, Bohmler U (1991) Splenic injury as a complication of endoscopy: two case reports and a literature review. Endoscopy 23: 302–304 13. Reynolds FS, Moss LK (1986) Splenic rupture following colonoscopy. Gastrointest Endosc 32: 307–308 14. Rockey DC, Weber JR (1990) Splenic injury following colonoscopy. Gastrointest Endosc 36: 306–309 15. Schwesinger WH, Levine BA (1979) Complications in colonoscopy. Surg Gynecol Obstet 148: 270–281 16. Smith LE (1976) Fiberopic colonoscopy and complications of colonoscopy and polypectomy. Dis Colon Rectum 19: 407–412 17. Taylor FC, Frankl HT (1989) Late presentation of splenic trauma after routine colonoscopy. Am J Gastroenterol 84: 442–443 18. Telmos AJ, Mittal VK (1977) Splenic rupture following colonoscopy. JAMA 237: 2718 19. Tuso P, McElligott J (1987) Splenic rupture of colonoscopy. J Clin Gastroenterol 9: 556–559

Surg Endosc (1997) 11: 54–55

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Determination of the learning curve of the AESOP robot L. K. Jacobs, V. Shayani, J. M. Sackier George Washington University, 2150 Pennsylvania Avenue NW, Suite 6B, Washington D.C. 20037, USA Received: 22 April 1996/Accepted: 17 June 1996

Abstract  Background: As the variety of procedures performed with laparoscopic technology increases, the skill levels and equipment demands also increase. Laparoscopic appendectomy, hernia repair, colon resection, and Nissen fundoplication all require someone whose only responsibility is to control the laparoscope and therefore the operative field. This is usually the most inexperienced person on the operating team. The Automated Endoscope System for Optimal Positioning (AESOP) robot provides a means to eliminate the need for the camera person, returns control of the camera and operative field to the operating surgeon, and enhances human performance. The purpose of this study was to evaluate the acquisition of skills to control the laparoscope in a satisfactory fashion.  Methods: We selected medical students as our study group because they have no prior experience in laparoscopic procedures. They performed a readily reproducible task in a pelvic trainer with hand control and with the AESOP robot. Their initial times are compared, as is the improvement in their times after 10 min of practice with the AESOP robot.  Results: These data show that in this study group use of the AESOP robot was not as fast as hand control but the skill to use it was learned as quickly. Additional features of the robut such as a steady view and the ability to acquire images and return to them reliably are other advantages. Conclusion: The AESOP robotic arm provides a stable support for the laparoscope during laparoscopic procedures which can be manipulated by the surgeon. We found that the time required to learn control of the laparoscope manually and with the AESOP robot is equal. Key words: Laparoscopy — AESOP robot — Learning curve

Presented at the Annual Meeting of the Society of American Gastrointestinal Endosocpic Surgeons (SAGES), Philadelphia, Pennsylvania, March 13–17, 1996 Correspondence to: J. M. Sackier

The range of laparoscopic procedures continues to increase. Intra-abdominal procedures now include cholecystectomy, hernia repair, appendectomy, colon resection, Nissen fundoplication, splenectomy, and lymph node biopsy. The equipment developed for use in laparoscopy also continues to increase. One of the newest creations is the Automated Endoscope System for Optimal Positioning (AESOP) robot, which controls the laparoscope during laparoscopic procedures. The AESOP robot is an FDA-approved robotic arm that is designed to control the laparoscope with either a foot pedal or hand control and to provide multiple degrees of  control. The use of the foot pedal allows the surgeon to control the field of view and have both hands free to operate, an essential component of advanced procedures [7]. Additionally, the current health-care climate demands the best use of resources, and it is quite simply wasteful to have a human fulfil the function that a robot can now so readily perform. Currently, during a laparoscopic procedure the view of  the operative field is controlled by the most junior person on the operating team. In university institutions this is often a medical student or junior resident, and in community hospitals or surgicenters this is an operating room technician or scrub nurse. This is a major change from open procedures where the operating surgeon obviously establishes the operative field. The use of the AESOP robot returns control of  the field to the operating surgeon and prevents the frustration of conveying often-confusing commands to the assistant; for instance, ‘‘move right’’ might mean the surgeons’ right, the assistant’s right, screen right, or the patient’s right—all potentially different directions. The view provided during the performance of laparoscopic surgery is dependent on the camera-holder’s (1) understanding of the operation, (2) fatigue level, and (3) ability to maintain concentration during the entire operation. We have all experienced the bored or fatigued camera holder drifting off the field. The use of robotics relieves the human of this boring task and provides a much more stable view [1, 8]. The use of the AESOP robot is expanding. The robot has the potential to decrease the number of people required for performance of the operation. Currently, during a laparoscopic appendectomy, hernia repair, Nissen fundoplication,

55

Fig. 1. Learning curve of acquisition of skills allowing control of the laparoscope using robotic and manual control over a 10-min practice time. Data is plotted as the mean plus or minus the standard deviation of the mean.

or colon resection, the role of one person in the operation is to hold the camera while the surgeon and assistant perform the operation. With the AESOP robot, the camera person is no longer required [4]. One of the commonly asked questions about the AESOP robot is, How long does it take to learn to control [10]? We have performed a randomized prospective study to evaluate this. Materials and methods The subjects were 31 medical students who had scrubbed on fewer than five laparoscopic procedures. Using a pelvic trainer they were asked to negotiate through a series of tasks. Each subject was given standardized instruction in use of laparoscope and the AESOP robot, but no time was given for practice with either instrument. Our goal was to compare the time it took for completion of the task with hand control as compared to completion of the task using the AESOP robot. No objective measurement of  satisfaction with the view obtained was attempted—this will be the subject of further evaluation. All tasks with the robot were completed using the foot pedal, as this is used most commonly in the operating room. The subjects were randomized by alternating hand control and robot control first. After timing baseline hand control and robot control, the subjects were allowed to practice alone for 10 min, during which they were timed every 2 min in both methods.

Results The mean times for hand control and robot control for 31 subjects at each testing time are plotted as the mean ± the standard deviation in Fig. 1. The two conditions are significantly different with a p > 0.0001 at each time point tested, indicating that there is a statistically significant difference in time required to perform the task with hand control and with robot control at each time interval. Examination of the curve also reveals that after 6 min of practice in each condition the curve levels off with very little improvement in time to perform the task. This indicates that the ability to control the laparoscope by robot or hand is learned at a nearly equal rate for the two conditions and that both conditions are learned in approximately 6 min. Discussion The use of robotics includes stereotactic frames and retractors in neurosurgery, femur preparation for total hip replace-

ment in orthopedic surgery [5, 6], transurethral resection of  the prostate in urologic surgery [9], and stapedotomy in otolaryngology. The advantages of robotics over humans in the performance of surgery include greater threedimensional spatial accuracy, more reliable and more repeatable outcomes, and greater precision [2]. The AESOP robot is another advancement in the development of instruments available for the performance of laparoscopic procedures. It is cost effective because it decreases by one the number of personnel required to perform many laparoscopic procedures. The learning curve, as demonstrated by this study, is approximately 6 min, and use of the robot is learned as quickly as control of the laparoscope with manual control. While manual control appears faster than robot control in this study, this has not been found in clinical trials where experienced attending surgeons evaluated the device and found AESOP-assisted laparoscopic operations to be faster with an assistant holding the endoscope. This was partially due to delays in image acquisition and partially due to multiple lens smearings more frequent with a human scope holder [3]. Most operative procedures require a consistent view of a small field. Changes in the operative field are usually small, and therefore, the difference in the time to change position with the robot and with hand control becomes negligible. The advantages of the AESOP robot are that it provides a more consistent view, decreases the number of personnel required to perform an operation, and most importantly, returns control of the operative field to the operating surgeon. We plan to follow this study with further controlled randomized trials using the robot. We intend to compare the time required to perform more functional tasks such as intracorporeal suturing in a pelvic trainer and the time required to perform procedures in the operating room.

References 1. Begin E, Gagner M, Hurteau F, de Santis S, Pomp A (1995) A robotic camera for laparoscopic surgery: conception and experimental results. Surg Laparosc Endosc 5: 6–11 2. Buckingham RA, Buckingham RO (1995) Robots in operating theatres. Br Med J 311: 1479–1482 3. Editorial (1994) Robotic arm returns direct scope control to surgeon. Minim Invasive Surg Nurs 8: 87–88 4. Gagner M, Begin E, Hurteau R, Pomp A (1994) Robotic interactive laparoscopic cholecystectomy. Lancet 343: 596–597 5. Mittelstadt B, Paul HA, Taylor RH, Kazanzides P, Zahars J, Williamson B, Petit R, Cain P, Kloth D, Rose L, Masits B (1993) Development of a surgical robot for cementless total hip replacement. Robotica 11: 553–560 6. Paul HA, Bargar WL, Mittlestadt B, Musits B, Taylor RH, Kazanzides P, Zuhars J, Williamson B, Hanson W (1992) Development of a surgical robot for cementless total hip arthroplasty. Clin Orthop 285: 57–66 7. Sackier JM, Wang Y (1994) Robotically assisted laparoscopic surgery—from concept to development. Surg Endosc 8: 63–66 8. Satava RM, Simon IB (1993) Teleoperation, telerobotics, and telepresence in surgery. Endosc Surg Allied Technol 1: 151–153 9. Timoney AG, Ng WS, Davies BL, Hibberd RD, Wickham JEA (1991) Use of robots in surgery: development of a frame for prostatectomy. J Endourol 5: 165–168 10. Unger SW, Unger HM, Bass RT (1994) AESOP robotic arm. Surg Endosc 8: 1131

Surg Endosc (1997) 11: 45–53

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Staple penetration and staple histological response for attaching an epimysial electrode onto the abdominal surface of the diaphragm using a laparoscopic approach B. D. Schmit,1 T. A. Stellato,2 J. T. Mortimer1 1 2

Applied Neural Control Laboratory, Case Western Reserve University, C.B. Bolton Bldg. 3rd Floor, Cleveland, OH 44106-4912, USA Department of Surgery, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA

Received: 2 April 1996/Accepted: 12 June 1996

Abstract  Background: Laparoscopic stapling was found to be a viable option for attaching epimysial electrodes onto the abdominal surface of the diaphragm. Stapling was preferable to suturing due to its simplicity and speed.  Methods: Of the two staplers tested in this study, the Ethicon Endopath was preferred over the Autosuture Endo Hernia because the staples did not penetrate the diaphragm when an electrode tab thickness greater than 0.75 mm was used.  Results: The thickness of the electrode tab was an important factor in determining staple penetration but large variation in penetration depth indicated that other factors may also play a role. An electrode tab thickness of 1.0–1.25 mm was suggested to minimize the risk of diaphragm perforation. Conclusions: The histological reaction to staples implanted up to 14 months was unremarkable, reflecting the safety of  laparoscopic staples for permanently anchoring electrodes on the diaphragm. Key words: Epimysial approach — Staple penetration — Staple histological response.

The objective of this study was to determine whether a laparoscopic stapler could be used to permanently attach an epimysial electrode onto the abdominal surface of the diaphragm without risk of perforating the diaphragm. Epimysial electrodes attached to the diaphragm using staples may be used for electrical activation of the diaphragm (diaphragm pacing) to provide ventilation for patients who have diaphragm paralysis, yet intact phrenic motor units. This approach to diaphragm pacing poses little or no risk for Correspondence to: Sensory Motor Performance Program, Rehabilitation Institute of Chicago, 345 E. Superior Street, Room 1406, Chicago, IL 60611, USA

phrenic nerve damage and is amenable to laparoscopicassisted implant. Laparoscopic implant of electrodes on the abdominal surface of the diaphragm reduces the risk of nerve damage associated with phrenic nerve cuff electrodes [16–18, 22]. Cuff electrodes require placement directly on the phrenic nerves using a cervical or thoracic approach [8, 9, 26]. As a result, the phrenic nerves are subject to surgical manipulation and mechanical trauma associated with the electrode [10]. In order to alleviate this risk, we developed a laparoscopic procedure for implanting intramuscular electrodes in the diaphragm [22]. This permits diaphragm pacing without physical contact with the phrenic nerves and benefits from the advantages of laparoscopic surgery including accelerated recovery, rapid convalescence, reduced wound infection, and facilitated surgery in the obese [3]. Intramuscular electrodes are effective for producing ventilation in dogs [17], but Peterson et al. found that 12 of 30 implanted electrodes perforated the diaphragm and three of these extended more than 1 cm into the thorax [17]. The risks associated with transdiaphragmatic electrode placement include pneumothorax and placement of the stimulating tip in the heart or lungs. In this study, we tested epimysial electrodes, which cannot perforate the diaphragm, as an alternative to intramuscular electrodes. This electrode type offers the additional advantage of an implant location that can be studied laparoscopically after attachment to the diaphragm. Two laparoscopic staplers, the Endopath (Ethicon Inc., Somerville, NJ) and the Endo Hernia (Autosuture Co., Norwalk, CT), were tested as an alternative to suturing epimysial electrodes in order to simplify the implant procedure. We hypothesized that when stapling an epimysial electrode onto the abdominal surface of the diaphragm, the staple penetration would be determined primarily by the thickness of the stapled element—the electrode tabs in this study. In a shortterm study, we studied the risk of perforation of the diaphragm and the short-term tissue response of the staples

46

Fig. 1. The Endopath (left) and Endo Hernia (right) staples. The staples are shown in open stage through two closing stages and in the final implanted configuration. The arcs traversed by the staple tips are demonstrated in the schematic below the photograph. Note that the point of maximum penetration may be greater than the penetration at either the starting or final position of the staple. Also note tissue would be gathered through the area

demarcated by the arc of the staple tines and compressed into the area of  final enclosure. Fig. 2. The silicone rubber test SET used for the short-term test of the staples. Thickness was 0.50, 0.75, 1.0, or 1.25 mm.

from both of the tested staplers. The long-term tissue response and the staple penetration of the Endopath were also tested. In both tests, we used staple penetration as an indication of the risk of diaphragm perforation. The effect of  electrode thickness on staple penetration was characterized and then implemented in the design of an epimysial electrode with a minimum danger of diaphragm perforation.

Methods The Endopath and the Endo Hernia are disposable, multifire staplers designed for use in laparoscopic hernia repair [11, 15, 23]. The Endopath has a rotating handle and contains 20 staples. The Endo Hernia has a rotating handle, an articulating head, and holds ten staples. The staples discharged by each stapler are shown in four stages of closure in Fig. 1.

One-week study A 1-week study was conducted to assess the risk of diaphragm perforation and determine the effect of electrode tab thickness on staple penetration for each stapler. The histological response of the muscle to the staples was also characterized after the 1-week implant. The stapler/staples were tested by attaching a simulated electrode tab (SET) onto the diaphragm muscle under laparoscopy. The SET, shown in Fig. 2, was made of Silastic (MDX 4-4210 Dow Corning Corp.) with a Dacron reinforcement. These implants were custom made with four different thicknesses—0.50 mm, 0.75 mm, 1.00 mm, and 1.25 mm—a length of 19.1 mm, and a width of 12.7 mm. One polypropylene mesh (Surgipro SPM-35, U.S. Surgical Corporation) was also tested in one of the three implants. Each SET was cleaned using a six-step cleaning process consisting of 5 min in a sonicator with the solvents Freon TMS, Safezone, Liquinox in distilled water, distilled water, 95% ethanol, and ultrapure water. Each implant was placed in a clean vial in ultrapure water and sterilized using gamma radiation. Eight SETs were implanted using aseptic technique in each of three dogs, weights 33, 27, and 38 kg. The dogs were preanesthetized with Surital (15 mg/kg), intubated, and shaved for surgery. Halothane anesthetic

Fig. 3. The electrodes used for the long-term staple test. Type 1 electrodes (right) had a tab thickness of 0.88 mm; type 2 (middle), 0.60 mm; and type 3 (left), 0.75 mm. The staples were placed through the tabs on either side of the center disk. Two to three staples were implanted per electrode.

(1–2%) was used for the remainder of the implant procedure. The dogs were treated with 500 mg intravenous oxacillin at the beginning and end of  surgery and cephalexin (500 mg, p.o. b.i.d.) for 3 days following surgery. Temperature was maintained using a heating pad and the dog was administered 500 ml 0.9% sodium chloride intravenously over the course of the implant procedure. Four SETs were stapled to the abdominal surface of each hemidiaphragm using a laparoscopic procedure. A 10-mm incision was made 1–3 cm caudal to the umbilicus, and a Veress needle was inserted to establish a carbon dioxide pneumoperitoneum. A 10-mm trocar was inserted and a 10-mm, 0° laparoscope was introduced. A 10/11-mm trocar and a 12-mm trocar were inserted 6–8 cm lateral and 3–5 cm rostral to the initial cannula on opposite sides. Each SET was introduced through the 12-mm cannula and a stapler through the 10/11-mm cannula. The SETs introduced on the right side were implanted on the right hemidiaphragm and vice versa, allowing a stapler approach from the contralateral cannula. The contralateral approach aided the stapling procedure by improving the stapler angle.

47

Fig. 4. Tissue sample from 1-week study. A perforated diaphragm from an Endo Hernia stapler through a 1.25-mm SET. A view of the sectional view of the diaphragm is shown in A. The abdominal surface of the diaphragm is shown on the top. Note tissue gathering by the staple upon closure. A staple is superimposed on the same tissue section, shown in B. The staple tines were located partly on the thoracic side of the diaphragm. Larger magnification of the tissue response is shown in C. There were no viable muscle fibers in the immediate vicinity of the staple. An inflammatory response extended from the abdominal surface through to the thorax including fibrin, active macrophages, and fibroblasts. The histology was consistent with a normal inflammatory response.

Following surgery, the dogs were X-rayed for pneumothorax. The animals were housed for 6, 6, and 7 days. At the time of explant, two of the dogs were anesthetized with sodium pentobarbital (30 mg/kg) and an aortic (whole body) perfusion was done (2 l 1% paraformaldehyde in 25 mM cacodylate buffer with 0.9 mM MgCl2 6H2O followed by 4 l 3.5% glutaraldehyde in 25 mM cacodylate buffer with 0.9 mM MgCl2 6H2O). Upon tissue explant, the diaphragm was placed in 10% formalin. The third animal was killed with an overdose of sodium pentobarbital and the diaphragm muscle was excised and placed in 10% formalin. Tissue samples were cut from the diaphragm and staples were removed. Each tissue sample was sectioned along the longitudinal tract of the staple. Samples were dehydrated and embedded in paraffin. Slices 7–10 ␮m thick  were stained with Hematoxylin and Eosin. Staple penetration was measured from images of the tissue section with a staple placed over the hypothetical staple tract (see Figs. 4 and 6). Images were then digitized and analyzed using JAVA video analysis software (version 1.4, Jandel Scientific). Staple penetration, muscle thickness, reactive layer thickness, and cross-sectional areas of obvious staple location were measured. ⅐



 Long-term study The Endopath was studied in a long-term study using the stapler to attach epimysial electrodes onto the abdominal surface of the diaphragm. The ability of the staples to hold a long-term implant in place was assessed and the histological response to the staples was determined. Staple penetration was measured for the long-term study and the effects of electrode tab thickness on staple penetration were documented. Three electrode designs (Fig. 3) were tested in a total of 11 dogs. Each dog was implanted with two to four electrodes that remained implanted for a minimum of 3 months. Each electrode type had a lead wire terminating in a disk, 6.4 mm in diameter. Electrode type 1 incorporated a stimulating surface located in a well formed by a Dacron-reinforced Silastic (MDX 4-4210) housing. Electrode types 2 and 3 incorporated a protruding hemispherical stimulating surface. Stapling tabs (12.7-mm diameter) were located on opposite sides of the center disk. Electrode type 2 did not have Dacron reinforcement while Dacron reinforcement was added to the ab-

48 Table 1. Staple penetration data for the Endo Herniaa

Dog

SET thickness (mm)

575 575 575 575 645 645 645 646 646 646 646

0.35 0.50 0.75 1.00 0.75 1.00 1.25 0.75 1.00 1.25 1.25

Complete penetration? Yes Yes Yes Yes Yes Yes No No Yes Yes Yes

a

Penetration distance was not measured, but the table indicates whether complete penetration of the diaphragm was detected on the histological sections. Complete penetration was defined as an active tissue response that extended from the peritoneum to the pleura. Nine of 11 samples completely penetrated the diaphragm. Interestingly, one of the nonpenetrating samples occurred with a 0.75-mm simulated electrode tab (SET), which was not the thickest sample size Fig. 5. Staple penetration vs SET thickness for the 1-week study. There was no apparent relation between staple penetration and SET thickness. Table 2. Staple penetration and SET thickness of the 1-week staple test for the Endopath

Dog

Mesh thickness (mm)

575 575 575 575 645 645 645 646 646 646 646

0.50 0.50 0.75 1.00 0.50 0.50 0.75 0.50 0.75 0.75 1.00

Staple penetration (mm)/  muscle thickness (mm) 2.25/2.48 1.40/2.25 1.28/4.58 1.06/2.90 1.38/3.53 0.86/2.70 1.82/2.44 1.75/2.56 1.33/3.02 1.33/2.90 1.45/2.29

dominal side of type 3 electrodes. The stapling tab thicknesses were 0.88 mm (type 1), 0.60 mm (type 2), and 0.75 mm (type 3). Each electrode was cleaned using a six-step cleaning process as described in the short-term study. Each electrode was sterilized by autoclave (type 1) or ethylene oxide gas (type 2 and type 3). A 2-week degassing period was allowed for ethylene-oxide-sterilized electrodes. The electrodes were implanted under laparoscopy as described in the short-term study. One to two electrodes were implanted on each hemidiaphragm. Two to three Endopath staples were used to fix each electrode onto the muscle. Lead wires to the electrodes exited the peritoneum at the xiphoid and traversed subcutaneously to an exit point on the back of the animal, midway along the scapula. The anesthesia, antibiotic regimen, and supportive care were identical to the 1-week test. Routine biweekly stimulation tests of supine anesthetized dogs were conducted for the duration of the study. These tests consisted of cyclic stimulation (2.5–5-s cycle time, 1.0–1.5-s inspiration time) of each electrode for periods of less than 1 h (type 1 and type 3) or for 1–5 h (type 2). Stimulation levels ranged from subthreshold to full recruitment with stimulation frequencies of 8–40 Hz. Type 1 electrodes were also stimulated up to 22 h/day between the biweekly tests with a 5-s cycle time, 1.5-s inspiration time using 20-Hz, current-controlled, charge-balanced, biphasic pulses with a 20-mA amplitude, 100-␮s pulsewidth, and 100-␮s delay between phases. Stimulation was applied simultaneously to one electrode on each hemidiaphragm, using the electrodes providing the greatest recruitment. Prior to explant, the electrodes were again viewed under laparoscopy to evaluate gross tissue reaction. Type 1 and type 3 electrodes were explanted 3 months after implant and type 2 electrodes were explanted 7–14 months after implant. Each dog was anesthetized with sodium pentobarbital (30 mg/kg) and placed in the supine position. After the laparoscopy, the dog was euthanized with an overdose of sodium pentobarbital and the dia-

phragm was excised. The muscle was fixed in 10% formalin for a minimum of 7 days. Tissue samples were sectioned along the staple tract and the staple was removed. Muscle sections were dehydrated, embedded in paraffin, and sliced (7–10 ␮m thick) for light microscopy. One set was stained with Hematoxylin and Eosin and another with Masson’s Trichrome. Slides were studied under light microscopy and images were digitized and analyzed with JAVA image analysis software. Staple penetration, muscle thickness, reactive layer thickness, and areas of obvious staple location were measured.

Results

One-week study

SETs attached to the diaphragm using the Endo Hernia stapler resulted in perforation of the diaphragm in nine of the 11 samples including the thickest (1.25 mm) SET. The postimplant X-rays indicated that each dog in the 1-week  study incurred a pneumothorax. A muscle section of a diaphragm that was perforated is shown in Fig. 4. The tissue reaction to the Endo Hernia staple was characterized by no viable muscle within the staple opening and an active foreign body response. The data are summarized in Table 1. The staple penetration data and corresponding SET thickness for the Endopath staples are shown in Table 2. None of the 11 Endopath staples perforated the diaphragm. When staple depth was plotted vs SET thickness, the plot in Fig. 5 was found. A significant trend was not present when testing the linear regression slope against zero. No significant staple depth difference was found even comparing the penetration using thinnest SET (0.50 mm) to the thickest SET (1.00 mm) using a Wilcoxon rank sum test. SETs of  thickness 1.25 mm were not used because they could not be stapled to the diaphragm using the Endopath stapler. A typical 1-week tissue response to the Endopath staple is shown in Fig. 6. The response was characterized by regenerating muscle cells and acute inflammatory cells such

49

Fig. 6. Tissue reaction to the Endopath staple at 6 days postimplant. The muscle section, extending from abdomen to the thorax, is shown in A. In contrast to the muscle section of the Endo Hernia staple shown in Fig. 4A, viable muscle fibers passed through the staple opening. The staple, superimposed on the histological section in B, did not completely penetrate the diaphragm. Higher magnification of the tissue response is shown in C. The nature of the tissue response was similar to the Endo Hernia but was limited to regions near the staple, particularly beneath the staple tines. This location was associated with the region of muscle that the staple passed through during closure.

as polymorphonuclear leukocytes and macrophages. Additionally, fibroblasts were present and active. The most remarkable feature of the tissue response was viable muscle in the enclosed portion of the staple. There was no indication of damage to many of these fibers. Tissue damage was located primarily inferior to the location of the staple where the staple apparently passed through the muscle during the stapling process.

Table 3. Staple penetration for the long-term staple testa

Electrode type

Mean penetration (mm)

STD error

STD dev

n

Tab thickness

1 2 3

1.40 2.62 1.66

0.07 0.31 0.08

0.33 1.19 0.25

37 20 21

0.88 0.60 0.75

a

 Long-term study

The staple penetration data for the long-term study are shown in Table 3. For calculation of the mean staple penetration, each datum was weighted by the staple area found

The electrode types are described in the text. Electrode types 1 and 3 were implanted for 3 months and electrode type 2 was implanted for 7–14 months. The n value indicates the number of staples tested for each electrode type. Staple penetration was calculated from histological slides of the staple tracts. The penetration for each sample was measured as the maximum penetration measured using a hypothetical staple location. The mean penetration was found using an arithmetic mean with a weight factor. The weight factor was determined by the area of staple tract present in the histological section

50

Fig. 7. Comparison of electrodes implanted for 3 months. The penetration is shown on the y-axis, and the electrode type on the x-axis. Electrode type 1 has a recessed stimulating surface and a tab thickness of 0.88 mm. Electrode type 3 has a protruding stimulating surface and a tab thickness of 0.75 mm. The staple penetration for all the samples is displayed. The circles represent the means with the corresponding standard error of the mean. Standard deviations are shown as dotted lines. The mean penetration for electrode type 3 was significantly greater than the mean penetration for electrode type 1 ( p < 0.02, Student’s t  test).

−4.25 (mm penetration)/(mm tab Fig. 8. Relation between staple penetration and tab thickness for all long-term electrode tests. A line with slope thickness) was fit to the data. The tab thickness had a significant effect on staple penetration (effect test, p < 0.0001). The mean diaphragm thickness was 4.02 mm ± 1.13 mm (standard deviation).

in the histological cross section. The mean staple penetration was 1.40 mm for electrode type 1 (thickness 0.88 mm), 2.62 mm for electrode type 2 (thickness 0.57), and 1.66 mm for electrode type 3 (thickness 0.75 mm). The standard deviation was 0.33 mm (24%) for type 1 electrodes, 1.19 mm (45%) for type 2 electrodes, and 0.25 mm (15%) for type 3 electrodes. The large standard deviation for the type 2 electrodes was partly attributed to the complete penetration of the diaphragm of five staples. When comparing only the electrodes implanted for 3 months, electrode type 3 was found to penetrate to a significantly greater depth than electrode type 1 ( p < 0.02, Student’s t  test). A comparison of these data is shown in Fig. 7. The mean muscle thickness was 4.02 mm with standard deviation of 1.13 mm. The relation between staple penetration and tab thickness for the long-term electrode test is shown in Fig. 8. A linear regression line with slope −4.25 (mm penetration)/  (mm tab thickness) was fit to the data. An effect test indicated that the tab thickness had a significant effect on staple penetration ( p < 0.0001). A typical long-term tissue response is shown in Fig. 9. The muscle surface reaction is primarily a reaction to the silicone rubber electrode. The response to the staple was characterized by a thin layer of mature collagen along the staple tract with little evidence of a cellular reaction.

Discussion Laparoscopic stapling was effective for attaching epimysial electrodes onto the abdominal surface of the diaphragm. This conclusion is based on the long-term tissue response to the staples and the absence of diaphragm perforation when

using electrode tab thicknesses greater than 0.75 mm. Staple penetration was the primary criterion for determining the safety of a laparoscopic electrode implant because it was directly related to the likelihood of diaphragm perforation and concomitant risk of inducing a pneumothorax. The thickness of the electrode tab was found to be an important factor in determining staple penetration but could not account for all variability in penetration depth. These data may be important for determining staple penetration risks associated with other surgical procedures such as staple repair of  diaphragmatic hernias [6, 14]. The Endopath stapler was preferred over the Endo Hernia for stapling electrodes onto the diaphragm because of  lower incidence of diaphragm perforation using stapling pad thicknesses between 0.5 mm and 1.25 mm. Nine of 11 Endo Hernia staples completely penetrated the diaphragm in the 1-week study compared to no diaphragm perforation for any of the 11 Endopath staples. We postulated that the higher risk of diaphragm perforation observed with the Endo Hernia occurred because of a greater penetration of the staple tines during staple closure (Fig. 1). As a result, only the Endopath staples were tested in the long-term study. The incidence of diaphragm perforation in the long-term study was limited to five of 16 staple implants using the thinnest electrode tab (0.60 mm). Conversely, none of the 58 staples used for stapling electrode tabs thicker than 0.75 mm resulted in perforation of the diaphragm. Thus, although a risk of diaphragm perforation existed with Endopath stapling, this risk was controlled by using a relatively thick electrode tab to limit the staple penetration. We concluded that the thickest possible electrode tab that still enables stapling should be used to minimize the risk of diaphragm perforation. This dimension was between 1.0 and 1.25 mm for the Endopath stapler.

51

Fig. 9. Tissue reaction to long-term staple test. This section was sampled 14 months after implant and stained for collagen with Masson’s Trichrome. Note in A that a collagen matrix was formed around the electrode tab implant. The staple tract, illustrated by superposition of a staple on the histological section in B, was easily identified in this section. Higher magnification of the staple tract is shown in C. There was a thin layer of mature collagen lining the staple tract and viable muscle fibers within the staple opening. There was no evidence of an active tissue response near the staple tract.

A significant correlation between staple penetration and SET thickness could not be demonstrated for the 1-week  study, but a strong correlation was found for the long-term study. The difference between the tests was attributed to the variation in staple penetration and the small sample size for the 1-week study. For the long-term study, linear regression of the staple penetration as a function of electrode tab thickness yielded a slope of −4.25 (Fig. 8), indicating that a small increase in electrode tab thickness caused a large decrease in staple penetration. We had hypothesized that the change in penetration would be inversely related to tab thickness with a slope of −1. The larger magnitude of the slope in the data implies that the staple penetration was not limited by the back of the staple (opposite the tines) pressing against the electrode in the final closed position.

In addition to the thickness of the electrode tab, other factors influenced staple penetration. For each electrode tab thickness, the mean staple penetration was less than the mean thickness of the diaphragm. Variation was observed for both the staple penetration data and the diaphragm thickness (Fig. 8), and diaphragm perforation occurred when particularly deep staple penetration coincided with a thin diaphragm. The variation in staple penetration could not be entirely accounted for by differences in electrode tab thickness. Other factors determining staple penetration may have included conditions associated with the surgery such as stapler angle, the pressure placed against the electrode during stapling, or the speed of staple closing. However, all staples were implanted using the same surgical protocol and by the same investigator. The variation in staple penetration ad-

52

equately reflected individual differences associated the staple implant procedure. Characterization of staple penetration may be important for other applications of laparoscopic staplers. The Endopath and Endo Hernia staplers were designed specifically for fixing a prosthetic mesh for inquinal hernia repair and stapling the peritoneum over the preperitoneal mesh in the same operation [11, 15, 23, 24]. Other staple devices have also been used for this procedure including a linear cutting stapler [2] and a laparoscopic clip applier [1, 5, 25], originally designed for ligation of the cystic duct for the laparoscopic colecystectomy [21]. In addition to laparoscopic inguinal hernia repair, the Endopath and Endo Hernia have been used for a number of other applications. Stapling a prosthetic mesh over hernias of the diaphragm, such as a herniation at the foramen of Morgagni [14] and extreme cases of paraesophageal hernia, have been accomplished [6]. In addition, abdominal wall hernias have been repaired using a prosthetic mesh and the Endo Hernia [12]. The Endopath has been used to reinforce a suture line in the repair of a diaphragmatic laceration [13] and for stapling the omentum to the gastric antrum, duodenum, and falciform ligament for repair of a perforated duodenal ulcer [4]. The Endopath has also been used to repair gastric lacerations high on the fundus with an omental patch stapled over the gastric staple repairs [7]. The wide variety of potential applications for single-staple devices which do not require an anvil for staple closure illustrates the versatility of these devices. As other laparoscopic procedures evolve, devices such as the Endopath and Endo Hernia may be used for many other specific applications. However, the applicability of a laparoscopic stapler requires knowledge of the characteristics of the stapler, the implanted staple, and the nature of the implant. We have characterized one parameter, staple penetration of the Endopath stapler, specifically for implanting epimysial electrodes onto the diaphragm. Many other parameters from different stapling devices may need to be characterized prior to choosing the appropriate instrument for new procedures. For example, the breaking or opening strength of the Endopath and Endo Hernia staplers has been studied to determine maximum loading for the laparoscopic inguinal hernia repair [19]. The histological response to the staples was one of the other staple parameters studied to determine the propriety of the Endopath stapler for attaching electrodes onto the abdominal surface of the diaphragm. The histological response to the Endopath staples was adequate for long-term anchoring of an epimysial electrode onto the surface of the diaphragm. The Endopath staples were nonstrangulating and non-necrosing as evidenced by the viable tissue observed in the enclosure of the staple in the 1-week test. Despite a significant cellular tissue response to the electrode tabs [20] (see also Fig. 9), the tissue reaction to the staples themselves was only one to two cell layers in thickness. In some cases the electrode tab tissue reaction obscured the histological response to the staple, especially for staples with small muscle penetration. The small amount of tissue reaction to the staples is especially remarkable considering the Silastic material did not elicit a tissue reaction capable of adhering the electrode tab to the surrounding tissue. This resulted in a transfer of stresses from the electrode to the staple and the tissue in proximity

with the staple and thus, the staple was the important fixating device. The absence of a cellular reaction in the staple tracts observed in the long-term study demonstrated the mechanical stability and biocompatibility of the staples. In conclusion, the applicability of the Endopath stapler for attaching epimysial electrodes to the abdominal surface of the diaphragm has been confirmed. The safety of the stapler was demonstrated by measuring and controlling the staple penetration and by examining the histological response to the implanted staples.  Acknowledgment. This work is supported by the Department of Veteran’s Affairs. We are grateful to Autosuture Co. for the donation of the Endo Hernia staplers and to Ethicon for the Endopath staplers used in this study. We thank Karl Storz Co. for the use of the laparoscopic equipment and the FES Core Laboratory at CWRU for the use of equipment for electrode fabrication. We also thank Dr. Roessmann of the Department of Pathology, University Hospitals of Cleveland, for his assistance with the histology.

References 1. Campos L, Sipes E (1993) Laparoscopic hernia repair: use of a fenestrated PTFE graft with endo-clips. Surg Laparosc Endosc 3: 35–38 2. Corbitt JD (1991) Laparoscopic herniorrhaphy. Surg Laparosc Endosc 1: 23–25 3. Cushieri A (1991) Minimal access surgery and the future of interventional laparoscopy. J Surg 161: 404–407 4. Darzi A, Cheshire NJ, Somers SS, Super PA, Guillou PJ, Monson JRT (1993) Laparoscopic omental patch repair of perforated duodenal ulcer with an automated stapler. Br J Surg 80: 1552 5. Dion YM (1993) Laparoscopic inguinal herniorrhaphy. Surg Laparosc Endosc 3: 451–455 6. Edelman DS (1995) Laparoscopic paraesophageal hernia repair with mesh. Surg Laparosc Endosc 5: 32–37 7. Frantzides CT, Ludwig KA, Aprahamian C, Salaymeh B (1993) Laparoscopic closure of gastric stab wounds: a case report. Surg Laparosc Endosc 3: 63–66 8. Glenn WWL, Phelps ML (1985) Diaphragm pacing by electrical stimulation of the phrenic nerve. Neurosurgery 17: 566–577 9. Glenn, WWL, Hogan JF, Loke JSO, Ciesielski TE, Phelps ML, Rowedder R (1984) Ventilatory support of the conditioned diaphragm in quadriplegia. New Engl J Med 310: 1150–1155 10. Glenn WWL, Brouillette RT, Dentz B, Fodstad H, Hunt CE, Keens TG, Marsh HM, Pande S, Piepgras DG, Vanderlinden RG (1988) Fundamental considerations in pacing of the diaphragm for chronic ventilatory insufficiency: a multi-center study. PACE Pacing Clin Electrophysiol 11: 2121–2127 11. Klein SR, Velez M, Davis IP (1992) Endoscopic hernia repair. United States Surgical Corporation, Norwalk, CT 12. LeBlanc KA, Booth WV (1993) Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc 3: 39–41 13. Marks JM, Ramey RL, Baringer DC, Aszodi A, Ponsky JL (1995) Laparoscopic repair of a diaphragmatic laceration. Surg Laparosc Endosc 5: 415–418 14. Newman L, Eubanks S, Bridges WM, Lucas G (1995) Laparoscopic diagnosis and treatment of Morgagni hernia. Surg Laparosc Endosc 5: 27–31 15. Peters JH, Ortega AE (1993) Laparoscopic inguinal hernia repair. In: Minimally invasive surgery. McGraw-Hill, New York, Health Professions Division pp 297–308 16. Peterson DK, Nochomovitz ML, DiMarco AF, Mortimer JT (1986) Intramuscular electrical activation of the Phrenic nerve. IEEE Trans Biomed Eng 33: 342–351 17. Peterson DK, Nochomovitz ML, Stellato TA, Mortimer JT (1994) Long-term intramuscular activation of the Phrenic nerve: efficacy as a ventilatory prosthesis. IEEE Trans Biomed Eng 41: 1127–1135 18. Peterson DK, Nochomovitz ML, Stellato TA, Mortimer JT (1994) Long-term intramuscular activation of the Phrenic nerve: safety and reliability. IEEE Trans Biomed Eng 41: 1115–1126 19. Powell JJ, Murray GD, O’Dwyer PJ (1994) Evaluation of staples and

53 prosthetics for use in laparoscopic inguinal hernia repair. J Laparosc Surg 4: 109–112 20. Schmit BD, Mortimer JT (1996) The tissue response to epimysial electrodes for diaphragm pacing in dogs. (in press) 21. Spaw AT, Reddick EJ, Olsen DO (1991) Laparoscopic laser cholecystectomy: analysis of 500 procedures. Surg Laparosc Endosc 1: 2–7 22. Stellato TA, Peterson DK, Nochomovitz M, Mortimer JT, Rhodes RS (1985) Diaphragm activation with laparoscopically placed intramuscular electrodes in dogs. Surg Forum 36: 297–299

23. Toy FK, Smoot RT (1992) Toy-Smoot laparoscopic hernioplasty. Del Med J 64: 23–28 24. Voeller GR, Mangiante EC, Britt LG (1993) Preliminary evaluation of  laparoscopic herniorrhaphy. Surg Laparosc Endosc 3: 100–105 25. Watson SD, Saye W, Hollier PA (1993) Combined laparoscopic incarcerated herniorrhaphy and small bowel resection. Surg Laparosc Endosc 3: 106–108 26. Wetstein L (1987) Technique for implant of phrenic nerve electrodes. Ann Thorac Surg 43: 336–339

Surg Endosc (1997) 11: 36–41

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Laparoscopic hernioplasty: Why does it work? E. L. Felix, C. A. Michas, M. H. Gonzalez Jr. The Center for Hernia Repair, 6191 North Fresno Street, Suite 102, Fresno, CA 93710, USA Received: 2 April 1996/Accepted: 7 June 1996

Abstract  Background: To understand how laparoscopic hernioplasty prevents early recurrence of hernia, we reviewed our first 1,000 patients. We analyzed the patients by age, sex, and hernia type and by whether their hernia was primary or recurrent.  Methods: The 1,000 patients had 1,336 hernias repaired by the transabdominal preperitoneal or the totally extraperitoneal approach. One thousand one hundred seventy-three hernias were primary and 163 were recurrent. The type of  hernia found varied with the patient’s age ( p < 0.001), and with whether the hernia was primary or recurrent ( p < 0.001); 14% of primary and 27% of recurrent hernias were complex, a surprisingly high incidence compared to historical controls.  Results: With a median follow-up of 2 years, five hernias have recurred and all were due to technical errors. Conclusions: The laparoscopic repair’s success may partially be due to its unique ability to diagnose previously overlooked complex elements. The defects are repaired without creating tension and the groin is reinforced with mesh, eliminating inherent weakness.

standard by which any hernioplasty is judged must take into consideration its recurrence rate, for in the end the incidence of recurrence determines the true cost of the procedure. Laparoscopic surgeons [1, 5, 8, 11, 18, 33] have considered all of the above criteria but maintain that recurrence rate should remain the most important measure in comparing results and success of hernia repair. They have continued to look for ways to reduce recurrence rates while reducing postoperative morbidity and have demonstrated that the laparoscopic approach is capable of achieving early recurrence rates of less than 2% [1, 5, 14, 19, 34]. To help understand why the technique has succeeded, we reviewed our first 1,000 patients who underwent a laparoscopic inguinal hernia repair. We analyzed not only short-term results but also the type of hernias found and how type related to patient’s age and sex and to whether hernias were primary or recurrent. To determine if the laparoscopic findings were influenced by the technique itself, we compared our results to results expected from a historical review of patients undergoing open hernia repairs.

Key words: Laparoscopic inguinal hernioplasty — Transabdominal preperitoneal (TAPP) — Totally extraperitoneal (TEP)

Between July 1991 and July 1995, 1,336 laparoscopic hernioplasties were performed in 1,000 patients. An endotracheal tube or a laryngeal mask  airway was used for general anesthesia in 992 patients. An epidural with sedation was employed in the other eight. Hernias were repaired using both the transabdominal preperitoneal approach (TAPP) and the totally extraperitoneal approach (TEP). Seven hundred ninety-eight hernias were repaired with a TAPP and 538 hernias with a TEP approach to the extraperitoneal space. All patients had a complete dissection (Figs. 1 and 2) and tension-free repair of the entire inguinal floor with polypropylene mesh anchored to the posterior wall (Fig. 3). Staples were placed in Cooper’s ligament and tranversalis fascia above the iliopubic tract. In every patient, mesh covered all three potential hernia sites, direct, indirect, and femoral. The repairs used a single-buttress technique with one large sheet of polypropylene mesh or a double-buttress technique with two separate sheets of  mesh. In single-layer repairs, a 6- by 6-inch piece of polypropylene mesh was cut large enough to cover the entire posterior floor of the groin. Mesh extended above the hernia defects and below Cooper’s ligament and iliopubic tract. In double-buttress repairs, an additional 21 ⁄ 2- by 4-inch mesh was placed over the internal ring, with a slit for the vas deferens and spermatic vessels. This mesh was covered with a second sheet of polypropylene in a manner identical to the single-layer technique.

Some surgeons feel that recurrence should no longer be the benchmark by which we judge hernioplasty techniques. They suggest that ease of repair, cost, complication rate, and time of rehabilitation should carry equal weight with recurrence rate in judging a hernioplasty technique [22]. While those are important considerations, we feel that the ultimate

Presented at the Annual Meeting of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), Philadelphia, Pennsylvania, USA, March 13–17, 1996 Correspondence to: E. Felix

Method

37

Fig. 1. A view of the posterior wall of the groin as seen in the TAPP approach ( IPT, iliopubic tract; IH, indirect hernia; DH, direct hernia; P, peritoneum; VD, vas deferens; FR, femoral ring; TV, testicular vessels; CL, Cooper’s ligament; IE, inferior epigastric vessels). Fig. 2. A view of the posterior wall of the groin as seen in the TEP approach ( IPT, iliopubic tract; IH, indirect hernia; DH, direct hernia; VD, vas deferens; FR, femoral ring; TV, testicular vessels; CL, Cooper’s ligament; IE, inferior epigastric vessels). Fig. 3. Polypropylene mesh anchored to the posterior wall covering all three potential hernia defects: indirect, direct, and femoral (ST, staples).

Patients undergoing the TAPP procedure had a 10/11-mm port placed in the umbilicus and one lateral to the inferior epigastric vessels on either side. The peritoneum was opened above the hernia defects and the posterior wall of the groin was dissected. A single-layer or double-buttress mesh repair of the entire floor was performed and the peritoneum was closed completely over the mesh. The totally extraperitoneal technique used three trocars placed in the midline. The extraperitoneal dissection was initiated with a balloon dissector and completed manually. A single sheet of mesh without a slit was used to cover the entire floor. The medial portion of the mesh was cut wider than the lateral part so that the medial mesh extended well above the direct floor and below Cooper’s ligament. If the testicular vessels prevented the mesh from lying flat over the lateral space, a double-buttress technique was chosen. As in TAPP repairs, the mesh was anchored to the posterior floor of the groin with staples. Patients were discharged from the recovery room when they were able to ambulate on their own. No restrictions were placed on the patients during the postoperative recovery period, and they were encouraged to return to normal activity and work as soon as they felt comfortable. Patients were evaluated by physical examination and interview at 1 week, 6 months, and yearly. All data obtained at surgery and follow-up examinations were prospectively recorded in a File Maker Pro computer database. Groups were compared statistically with Microsoft Excel’s chi test. Historical comparisons were made from a review of the literature.

Results

One thousand three hundred thirty-six hernias were laparoscopically repaired in 1,000 patients. Three hundred thirteen patients had simultaneous bilateral repairs and 23 had staged bilateral repairs. Two laparoscopic approaches to the posterior floor of the groin, the transabdominal preperitoneal and the totally extraperitoneal, were used and two methods of mesh repair were used in each group (Fig. 4). There were 919 male and 81 female patients. The age of  the patients ranged from 13 to 93 with a mean of 49 years (Fig. 5). Eleven hundred seventy-three hernias repaired were primary and 163 were recurrent. Seven hundred ninety-nine hernias were indirect, 309 direct, 16 femoral, 212 pantaloon, and 69 hernias had an additional femoral component. The type of hernia found was related to the age of the patients ( p < 0.001) (Fig. 6) and to whether the hernia was primary or recurrent ( p < 0.001) (Fig. 7). Twenty-seven percent of recurrent hernias were complex, compared to 14% of primary hernias (Fig. 8). There was no significant difference in type of hernia or in age or sex of patients

38

Fig. 4. The graph shows the number of hernias repaired with a single or double layer of mesh according to the laparoscopic approach used, TAPP or TEP.

Fig. 5. The distribution of patients by age for each laparoscopic approach.

Fig. 6. The graphs show the type of hernia found at operation in patients with a primary or recurrent hernia according to their age.

according to which approach, TAPP or TEP, was used. Because of surgeon bias, the percent of recurrent hernias repaired by TAPP approach was significantly higher than by TEP approach, 74% vs 26% ( p < 0.001). The first TEP repairs were not performed until September of 1993, and its use for recurrent repairs was limited until adequate experience was achieved (Fig. 9). Patients were followed from 8 to 56 months with a median of 2 years. Follow-up examinations were scheduled at 1 week, 6 months, 1 year, and each year thereafter. Five patients have had failure of their hernia repair. Three were after TAPP and two after TEP repairs. The patients had symptoms of recurrence within 3 months of  repair and were reexplored laparoscopically. Four were repaired at exploration and one was converted to an anterior repair. The latter was previously repaired laparoscopically at another hospital before our laparoscopic repair. All patients are now hernia free. Four have been followed for more than 6 months and one patient was repaired within the last 30 days. All five recurrences were related to technical errors and

all presented within 6 months of initial repair. They were due to a retained lipoma of the cord in one case, poor lateral fixation of the mesh in three cases (one secondary to a hematoma), and a technical problem in a patient repaired laparoscopically at another institution. In the last patient, the laparoscopically placed mesh from the primary repair could not be separated from the bladder. An indirect defect was seen and repaired, but a recurrent direct defect was missed. It was later repaired with an anterior approach, placing mesh between bladder and fascia with a second piece anterior to the defect in the fascia. Of the total number of patients, 2.4% have undergone a remedial operation after hernioplasty, five for recurrence and 19 for other complications. Seroma was the most common complication following laparoscopic hernioplasty, but resolved spontaneously or was successfully aspirated in all but two patients who later required excision of a persistent fluid collection. Eleven patients developed a hydrocele from several months to 2 years after operation, and six required excision because of symptoms. Three patients developed chronic pain and underwent open exploration of the groin.

39

Fig. 7. The graph compares the percent of indirect, direct, pantaloon, and femoral hernias found in primary and recurrent repairs.

Fig. 8. The graph compares by age the percent of complex hernias found at operation in patients with a primary or recurrent hernia.

One patient developed a small-bowel obstruction which was repaired laparoscopically on the 3rd postoperative day, and one patient was explored for a trocar injury of the small bowel on the 1st postoperative day. Six patients developed a trocar hernia and all have undergone an open repair.

Comments

Inguinal hernia repair is one of the most common operations in the United States [4]. The number of procedures performed annually has risen to almost 750,000 [21]. There has been, however, no one approach which has been accepted as the standard, but rather several which vary according to individual surgeons’ biases [16]. Despite a gradual evolution in technique, overall recurrence rates in the United States remained at approximately 10% [2, 21]. Lichtenstein et al. [12], Stoppa et al. [31], Nyhus et al. [15], and Wantz [35] stressed the importance of reducing tension and reinforcing intrinsic weakness of the groin to prevent recurrence. In centers specializing in hernioplasty, where attention was paid to these underlying causes of failure and to

Fig. 9. The graph shows the number of hernias repaired by a TAPP or TEP approach per year over the 4 years of the study.

Fig. 10. The graph compares by age the percent of hernias repaired that had a femoral hernia in addition to a indirect, direct, or pantaloon in patients with a primary or recurrent hernia.

limiting technical errors by increasing individual surgeon’s operative experience, the incidence of recurrence was reduced [3, 26, 28]. Over the last few years, a laparoscopic approach has evolved based on the open posterior repair [6, 11, 14, 34]. The approach was designed to reduce postoperative recovery and still address the causes of failure. It reduces tension and reinforces intrinsic weakness by using a meshbuttressed approach similar to that of Stoppa [32]. In addition, the technique gives surgeons an overview of the entire posterior wall of the groin. It may be this magnified wideangle exposure of the groin floor that distinguishes the laparoscopic technique from other mesh-reinforced repairs, as well as open posterior repairs. Our laparoscopic examination of 1,000 patients found that 14% of primary and 27% of recurrent hernias were pantaloon, and up to 11% of hernias repaired had a femoral component along with a primary defect (Fig. 10). Our findings were in contrast to those of several reviews that utilized an open technique [7, 10, 13, 20, 23–25, 28]. These investigators either failed to comment on whether patients had a

40 Table 1. The incidence of simple and complex hernias found in several large reviews of open recurrent hernioplasties (FC a femoral component in addition to a direct or indirect hernia)

Report

Indirect

Direct

Pantaloon

Femoral

FC

Mardsen [13] Ijzermans et al. [10] Ryan [24] Postlethwait [20] Rutledge [23] Lichtenstein et al. [12]

44% 30% 47% 59% 51% 44%

52% 58% 40% 35% 29% 47%

4% 7% 10% 2% 15% 7%

3% 3%

1% 1%

1%

complex hernia (a hernia with more than one defect in the wall), or, when complex hernias were identified, the overall incidence of these combined direct, indirect, and femoral hernias was low. Table 1 details six of these reports. The incidence of complex hernias identified in these reports was much lower than we found using a laparoscopic approach. Why were so many more complex hernias found in our study? The answer would have to be that either our population of patients was different than those in previous studies or we are better able to identify the defects in the inguinal floor of our patients. If the latter is true, one must suspect that the view given us by the laparoscope was responsible for our success. If hernias are more complex than previously appreciated, we would expect early recurrence rates to be increased when elements of the hernia are overlooked. In Postlethwait’s experience, 24% of indirect recurrent hernias were caused by a missed hernia [20]. Ryan [24] found as many as 17% of all recurrent hernias were due to missed defects at the original operation. The laparoscopic view might be key in improving our level of early success. This is particularly true in older patients and those with recurrent hernias. The incidence of complex hernias (pantaloon hernias or hernias with an additional femoral component) increased with patient’s age and with whether the hernia had previously been repaired. The ability of the laparoscopic approach to expose these otherwise-occult defects might be part of the reason for our technique’s success. Recurrences due to missed hernias tend to present early in the postoperative period [7, 20, 24]. In Shultz’s et al. [29] first report of laparoscopic repairs, there was an extremely high incidence of early failures. Almost 25% of repairs recurred, because his technique limited dissection of the groin and failed to identify the second component of pantaloon hernias which were present. This flaw in technique resulted in missed hernias and did not take advantage of the laparoscopic exposure. In a subsequent study by Shultz et al. [30], in which the entire floor was exposed, recurrences were totally eliminated. The low incidence of early failures in our review, less than 1% after a median follow-up of 2 years, may have in part been due to the ability of the laparoscopic technique to find and repair all components of the hernia. A complete dissection of the entire posterior wall of  the groin was performed in all but one patient. The dissection in this patient was impossible because mesh placed at an earlier operation at another institution prevented dissection of the medial wall. A direct component of a pantaloon recurrence was missed and the repair failed. Technical error, the other reason for early recurrence [24], was the cause of the other failures seen in our study.

The Shouldice Clinic [3] has shown that the key to preventing technical errors with an anterior approach is experience. We must assume that this will be the case for laparoscopic techniques. Learning curves have already been demonstrated for other laparoscopic procedures such as cholecystectomy [9]. It appears that our laparoscopic technique was successful over the short term because it eliminated one of the main causes of early recurrence, missed hernias [20, 24]. It should continue to work over the long term, because it reduces tension [27] and buttresses intrinsic collagen deficits [17], the causes of late recurrence. The key to maintaining such a low recurrence rate will be the avoidance of technical errors. Only experience and continued attention to detail will make this possible. Schapp et al.’s dismal experience with an open posterior approach has demonstrated this all too well [25]. If the laparoscopic hernioplasty works, which patients should be selected for the approach? Some insurance companies have suggested that the laparoscopic approach be restricted to young working patients with bilateral hernias or patients with recurrent hernias [personal communication]. Because hernias tend to be more complex in older patients as well as those with a previous repair, these patients probably benefit from a decreased incidence of recurrence to a greater degree than young patients with a primary hernia. Young, motivated patients, however, benefit most from a shortened recovery period and were able to quickly return to work without fear of tension or intrinsic weakness disrupting their repair. Patients over 65 were able to return to normal daily activities in less than a week, however, just as quickly as younger patients. All adult patients, young and old, laborers, office workers and retirees, appear to have benefited from the laparoscopic approach; therefore, any future studies comparing different hernia repairs should take all of the groups into consideration. A recent editorial proposed that immediate cost and ease of repair should be viewed as the most important goals of  hernia repair in selected patients [22]. These goals are important, but should be secondary to the incidence of recurrence and morbidity of recovery associated with the repair. The true cost of any hernia repair to patients and society can be reduced only by retaining these latter goals. Before we include or exclude any technique in our arsenal of weapons, we must understand the true benefits and risks of the procedure in the hands of surgeons experienced in the technique [1, 6, 11, 14, 19].

References 1. Arregui ME, Navarrete J, Davis CJ, Castro D, Nagan RF (1993) Laparoscopic inguinal herniorrhaphy: techniques and controversies. Surg Clin North Am 73: 513–527 2. Bassini E (1887) Nuovo Metodo Sulla Cura Radicale dell’ Ernia Inguinale. Arch Soc Ital Chir 4: 380 3. Ben David R (1989) New techniques in hernia repair. World J Surg 13: 522–531 4. Conceptualization and measurements of physiological health for adults (1983) Selected Rand Abstracts 211: 25 5. Felix EL, Michas CA, McKnight RL (1994) Laparoscopic herniorrhaphy transabdominal preperitoneal floor repair. Surg Endosc 8: 100– 104 6. Felix EL, Michas CA, Gonzalez M (1995) Tapp vs Tepp laparoscopic hernioplasty. Surg Endosc 9: 984–989

41 7. Glassow F (1970) Recurrent inguinal and femoral hernia. Br Med J 1: 215–219 8. Fitzgibbons R, Camps J, Comet D, Nguyen N, Litke B, Annibali R, Salerno G (1995) Laparoscopic inguinal herniorrhaphy results of a multicenter trial. Ann Surg 221: (1)3–113 9. Hunter JG, Sackier JM, Berci G (1994) Training in laparoscopic cholecystectomy: quantifying the learning curve. Surg Endosc 8: 28–31 10. Ijzermans J, Wilt H, Hop W, Jeekel H (1991) Recurrent inguinal hernia treated by classical hernioplasty. Arch Surg 126: 1097–1100 11. Kavic MS (1995) Laparoscopic hernia repair: three year experience. Surg Endosc 9: 12–15 12. Lichtenstein II, Shulman AL, Amid PK (1989) The tension-free hernioplasty. Am J Surg 157: 188–193 13. Marsden AJ (1988) Recurrent inguinal hernia—a personal study. Br J Surg 75: 263–266 14. McKernan JB, Laws HL (1993) Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach. Surg Endosc 7: 26–28 15. Nyhus LM, Pollak R, Bombeck CT, Donohue P (1988) The preperitoneal approach and prosthetic buttress repair for recurrent hernia. Ann Surg 208: 722–727 16. Nyhus LM, Condon RE (1995) Hernia. JB Lippincott, Philadelphia, PA 17. Peacock EE, Madden JW (1974) Studies on the biology and treatment of recurrent inguinal hernia II morphological changes. Ann Surg 179: 567–571 18. Phillips E, Arregui M, Carrol J, Corbitt J et al. (1995) Incidence of  complications following laparoscopic hernioplasty. Surg Endosc 9: 16–21 19. Phillips EH, Rosenthal R, Fallas M, Carroll B, Arregui M, Corbitt J, Fitzgibbons R, Seid A, Schultz C, Toy F, Wadell R, McKernan B (1995) Reasons for early recurrence following laparoscopic hernioplasty. Surg Endosc 9: 140–145 20. Postlethwait RW (1971) Causes of recurrence after inguinal herniorrhaphy. Surgery 69: 772–775 21. Rutkow IM, Robbins AW (1993) Demographic, classificatory, and socioeconomic aspects of hernia repair in the United States. Surg Clin North Am 73: 413–426

22. Rutkow IM (1995) The recurrence rate in hernia surgery. How important is it? Arch Surg 30: 575–576 23. Rutledge R (1988) Cooper’s ligament repair: a 25 year experience with a single technique for all groin hernias in adults. Surgery 103 (1): 1–10 24. Ryan EA (1953) Recurrent hernias—an analysis of 369 consecutive cases of recurrent inguinal and femoral hernias. Surg Gynecol Obstet 96: 343–354 25. Schapp HM, Van de Pavoordt HD, Bast TJ (1992) The preperitoneal approach in the repair of recurrent inguinal hernias. Surg Gynecol Obstet 174: 460–464 26. Shouldice EE (1953) The treatment of hernia. Ontario Med Rev 20: 670–684 27. Shulman AG, Amid PK, Lichtenstein I (1992) Plug repair of recurrent inguinal hernias. Contemp Surg 40: 30–33 28. Shulman AG, Amid PK, Lichtenstein I (1992) The safety of mesh repair for primary inguinal hernias: results of 3019 operations from five diverse surgical sources. Am Surg 58: 255–257 29. Shultz L, Graber J, Pietraffita J, Hickok D (1990) Laser laparoscopic herniorrhaphy: a clinical trial—preliminary results. J Laparoendosc Surg 1: 41–45 30. Schultz L, Cartuill J, Graber J, Hickok D (1994) Transabdominal preperitoneal procedure. Semin Laparosc Surg 1 (2): 98–105 31. Stoppa R, Rives JL, Walamount C, Palot JP, Verhaege PJ, Delattre JF (1984) The use of Dacron in the repair of hernias of the groin. Surg Clin North Am 64(2): 269–285 32. Stoppa R (1989) The treatment of complicated groin and incisional hernias. World Surg 13: 545–554 33. Tetik C, Arregui ME, Dulucq JL, Fitzgibbons RJ, Franklin ME, McKernan JB, Rosin RD, Shultz LS, Toy FK (1994) Complications and recurrences associated with laparoscopic repair of groin hernias. A multi-institutional retrospective analysis. Surg Endosc 8: 1316–1323 34. Voeller GR, Mangiante EC, Britt LG (1993) Preliminary evaluation of  laparoscopic herniorrhaphy. Surg Laparosc Endosc 3(2): 100–105 35. Wantz GE (1994) Properitoneal hernioplasty with unilateral giant prosthetic reinforcement of the visceral sac. Contemp Surg 44(2): 83– 89

Surg Endosc (1997) 11: 29–31

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Herniography and ultrasonography A prospective study comparing the effectiveness of laparoscopic hernia repair with extraperitoneal balloon dissection O. N. Dilek,1 M. Bozkurt,2 H. Arslan,2 E. Kisli,1 N. Poyraz,2 M. Berberoglu3 1

Department of General Surgery, School of Medicine, Yuzuncu Yil University, Van, Turkey Department of Radiology, School of Medicine, Yuzuncu Yil University, Van, Turkey 3 ITEM, Advanced Medical Technologies Education Center 2

Received: 29 March 1996/Accepted: 28 May 1996

Abstract  Background: This study was designed to assess differences between pre- and postoperative herniography and ultrasonography in inguinal hernia performed laparoscopically with balloon dissection and mesh without suture.  Methods: Pre- and postoperative herniographic and ultrasonographic findings were analyzed in ten consecutive patients. Postoperative ultrasonography was performed on the 3rd and 7th days and herniography was performed on the 7th day.  Results: Following the operation both the herniography and ultrasonography were almost normalized to a great extent in nine patients. Overall, minimal impaired continence was recorded by herniography in one patient. Also, we detected nonspecific soft-tissue thickening at the operation site in ultrasonographic examination in four patients. Conclusions: As for inguinal hernias, compared with other operative modalities of treatment, laparoscopic hernia repair with extraperitoneal balloon dissection and mesh without suture is a highly successful procedure and its minimal morbidity is well accepted by the patient. Key words: Herniography — Inguinal hernia — Laparoscopic herniorrhaphy — Ultrasonography — Mesh

Hernia repair with laparoscopic procedure has been used increasingly in recent years and may be an alternative to conventional hernia repair methods. Today, various meth-

Presented at the Annual Meeting of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), Philadelphia, Pennsylvania, USA, March 13–17, 1996 Correspondence to: O. N. Dilek, Tip Fakultesi Hastanesi, Maras Cad. Van, Turkey

ods used for hernia repair with laparoscopic procedures are still being practiced. Total extraperitoneal (TEP)and transabdominal methods are the most preferred. They can be applied in various ways to evaluate the effectiveness of an attempt made to patients with hernia. The diagnosis and the treatment of hernias can be evaluated using pneumoperitoneum, computerized tomography, herniography, ultrasonography (USG), losing of hernia sacs with physical examination, and subjective complaints of the patients [2, 5, 6]. We have not coincided with any study made radiologically for evaluating in postoperative period of laparoscopic hernia repair in our Medline researching. In this study, the results of herniography and ultrasonography done in pre- and postoperative periods on ten patients who were operated on with the TEP method were evaluated.

Materials and methods In this prospective study, herniorrhaphy was applied to ten consecutive patients, nine of whom were male and one female. Five right, three left, and two bilateral inguinal hernias were present in the patients. A balloon dissector was used extraperitoneally and 8 × 12 cm Prolene mesh was placed in the retroperitoneal region. Fixation of mesh was not done (Fig. 1). Herniography was performed preoperatively on the patients and on the 7th day in the postoperative period. USG was performed preoperatively and repeated on the 3rd and 7th days in the postoperative period. Before the herniography was performed, patients defecated and urinated, which reduces the risk of perforation. The patient was laid in a supine position and the abdominal wall was cleaned. Via the left lower quadrant, a needle penetrated the lateral border of the rectus muscle and entered the abdominal cavity. The needle was 10 cm long and 0.9 mm in caliber. Under fluoroscopic control 200 cc of contrast substance was in jected. When the injection was completed, the patient was put in a prone position. The patient was moved into different positions to collect contrast substance in peritoneal sacs. Then frontal and oblique views were taken with the patient in a prone position and straining and with the tube angled 20° caudally. Diagnostic criteria were the same as those reported previously in herniographic series [2].

30

Fig. 1. Prolene mesh was placed in retroperitoneal region without suture.

Results

The needle entered the bowel of a patient during herniography but it caused no problem. There were no complications in other patients in the pre- and postoperative periods. A hernia which had not been diagnosed previously was detected on the oppositeside in two patients who had been given a herniography (Fig. 2). Compared with postoperative herniography, it was observed that improvement reached nearly normal in nine cases (Fig. 3). Following the operation, in a patient, recurrent minimal hernia was diagnosed on the left side with herniography, but it was not diagnosed with clinical examination. It was thought that the cause of  this situation could be displacing or sliding of mesh (Fig. 4). While hernia sacs were diagnosed with USG in the preoperative period, they were not observed in the postoperative period. Following the operation, 3 × 3 cm hematoma in one patient, localized residual CO 2 bubbles in two cases, localized edema at the hernia orifice, and also echo-lucent thickening of the spermatic cord in four patients were detected by USG. No surgical fleece (Prolene mesh) was traced in any patient. However, we failed to obtain more specific findings related to the diagnosis and treatment.

Discussion

In surgery and urology clinics, herniography is usually used to illuminate the etiology of pain of unknown cause in the pelvic area and to diagnose uncertain or occult hernias in the preoperative period [1–3]. Herniography was first descirbed in Canada in 1967 [1]. Ekberg et al. reported that the herniography was a highly sensitive and safe method of diagnosis. With preoperative herniography, Ekberg et al. diagnosed ipsilateral multiple hernia that was undiagnosed previously in 6% of cases [4]. It is clear that this procedure will affect the form and success of treatment. We diagnosed an

Fig. 2. Herniogram of 36-year-old man with right-sided inguinal hernia. The hernai which had not been diagnosed previously was diagnosed in left groin (arrows). Fig. 3. Postoperative herniogram of 41-year-old man with left-sided inguinal hernia. There is no difference in anatomic and radiologic appearance between left and right sides. Fig. 4. Postoperative herniogram of the patient reveals a small recurrent inguinal hernia in left groin (arrows). Physical examination was normal.

31

additional hernia in our two cases, too. With the aim of  observing the effectiveness of laparoscopic hernioplasty, herniography was used in the postoperative period, too, and x-rays were compared. Normal anatomic views were seen on the x-rays in the postoperative period. Technically and anatomically, laparoscopic hernioplasty is an attempt of  posterior wall. This situation showed that the operation technique was well adjusted and effective for anatomic structure. In our study, we established that the following up hernia with USG was more difficult (the related data was less). But it gives more sensitive results in the diagnosis of localized fluid collection. The signs, other than these, remained uncertain and nonspecific. As a result, the etiology of pain of unknown cause can be illuminated with preoperative herniography. Moreover, hernias that were undiagnosed previously can be established with herniography, and it is clear that this will affect the form and success of the treatment. The operation’s effectiveness can be established with herniography in the post-

operative period. As a matter of fact, herniography is a safe and sensitive technique. Laparoscopic hernia repair that is more effective, safer, more comfortable, and apparently is an alternative to conventional hernioplasty results.

References 1. Eames NWA, Deans GT, Lawson JT, Irwin ST (1994) Herniography for occult hernia and groin pain. Br J Surg 81: 1529–1530 2. Ekberg O (1981) Inguinal herniography in adults: technique, normal anatomy, and diagnostic criteria for hernias. Radiology 138: 31–36 3. Ekberg O, Abrahamsson P, Kesek P (1988) Inguinal hernia in urological patients: the value of herniography. J Urol 139: 1253–1255 4. Ekberg O, Lasson A, Kesek P, Van Westen D (1994) Ipsilateral multiple groin hernias. Surgery 115: 557–562 5. Hergan K, Scheyer M, Oser W, Zimmerman G (1995) The normal ultrasonic findings after a laparoscopic inguinal hernia operation. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 162: 29–32 6. Timberlake GA, Ochsner MG, Powell RW (1989) Diagnostic pneumoperitoneum in the pediatric patient with a unilateral inguinal hernia. Arch Surg 124: 721–723

 EndoScope: world literature reviews Surg Endosc (1997) 11: 77–80

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Original articles from a wide range of international surgical journals are selected by our editors and presented here as a structured summary and critical review. EndoScope serves as a quick and comprehensive survey of the expansive endoscopic literature from all the corners of the globe.

The value of minimal access surgery in the staging of patients with potentially resectable peripancreatic malignancy Conlon KC, Dougherty E, Klimstra DS, Coit DG, Turnbull AD, Brennan MF Ann Surg (1996) 223(2): 134–140 Objective: To explore the accuracy of laparoscopic staging of patients with potentially resectable peripancreatic malignancy. Methods: Between December 1992 and August 1994, 115 patients with radiologically resectable peripancreatic tumors were prospectively enrolled in the study and underwent extended laparoscopy before a planned curative resection. This technique of detailed laparoscopic staging included the assessment of the peritoneal cavity, liver, lesser sac, porta hepatis, duodenum, transverse mesocolon, and celiac and portal vessels. Results: Of the 115 patients, 108 patients underwent complete laparoscopic examination. Of the 67 patients considered resectable, 61 resections were performed. Of the 115 patients, 80 underwent open exploration with an overall resectability rate of 76%, as compared to the 35% resectability rate for the previous 1,135 patients who underwent laparotomy prior to December 1992. The positive predictive index, negative predictive index, and accuracy of laparoscopy were 100%, 91%, and 94%, respectively. There were no intraoperative or postoperative complications related to the laparoscopic procedure. Conclusions: Laparoscopy is an important component in the staging of the patients with presumed resectable peripancreatic tumors. Staging laparoscopy may help reduce the rate of unnecessary laparotomy in patients with unresectable tumors. Comment: This study, although not randomized, and although compared to a historical control group, brings us one step closer to recognizing and accepting the role of staging laparoscopy in the management of patients with presumed resectable peripancreatic tumors. Clearly, a prospective randomized study is needed before the final chapter on this controversy is written. In addition, two issues must be pointed out about this study: (1) The staging technique described requires advanced laparoscopic skills, and (2) this study does not address the financial issues important to this discussion.

Thoracoscopic implantation of an epicardial pacemaker (case report) Robles R, Pinero A, Lujan JA, Parrilla P Br J Surg (1996) 86: 400 Objective: To perform thoracoscopic implantation of epicardial pacemakers in patient with auriculoventricular block  (AVB) in whom peripheral vein insertion of the electrocatheter is not possible. Methods: A 55-year-old woman with chronic renal failure and a right arteriovenous fistual for hemodialysis and a thrombosed innominate venous trunk required a pacemaker for treatment of high-grade AVB. Following failure of  transvenous insertion of the electrocatheter, a thoracoscopic approach for implantation of the epicardial electrode was selected. Using a 10-mm trocar in the sixth intercostal space at the midaxillary line and two 5-mm trocars in the fourth and seventh intercostal spaces at the anterior axillary line, a 4-cm pericardial window was created. The electrocatheter was inserted and screwed into the muscular mass of the myocardium, proximal to the cardiac apex. The electrocatheter was connected to the generator, which was implanted under the fascia of the greater oblique. A pleural drain was inserted and removed after 48 h. Following confirmation of  a functional pacing device, the patient was discharged home 72 h after operation. Comment: The described technique appears to be a good alternative to a subxiphoid approach or a thoracotomy for implantation of epicardial electrocatheters when the transvenous approach is not possible. This technique may gain universal acceptance if the complication rate (in the hands of large number of surgeons and for a large number of  patients) is kept at a minimum.

Laparoscopic resection of solid liver tumours Gugenheim J, Mazza D, Kathouda N, Goubaux B, Mouiel J Br J Surg (1996) 83: 334–335 Objective: To describe the laparoscopic technique for nonanatomic liver resection.

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Methods: Three patients, ages 47, 44, and 33, had preoperative diagnosis of liver lesions. The first patient had previous diagnosis of breast cancer with a presumed liver metastasis. Patients 2 and 3, who had been on oral contraceptives for 15 and 16 years, respectively, were diagnosed with 8-cm and 4-cm liver lesions, respectively. Preoperative evaluation of these lesions could not rule out hepatocellular carcinoma. All patients underwent laparoscopic, nonanatomic liver resection. Six laparoscopic ports were used in each case. Ultrasonographic dissector and absorbable clips were used to enhance the safety of the resection. Specimens were removed using endoscopic retrieval bags, either through enlarged umbilical trocar sites or though a McBurney incision (patient 2 with an 8-cm lesion). Results: Histologic examination confirmed metastatic lesion in patient 1 and focal nodular hyperplasia for patients 2 and 3. No blood transfusion were necessary. Patients were discharged in 5–7 days with no perioperative complications. The patient with metastatic lesion is alive after 17 months with no evidence of tumor recurrence. Comment: In the three cases presented, the laparoscopic liver resections performed are most likely identical to that performed had the patients undergone open liver resection. The laparoscopic approach is therefore justifiable. Whether or not the laparoscopic approach can be applied to primary liver neoplasms requiring anatomic liver resection is not addressed by this report. In addition, advantages of laparoscopic approach in this setting are anecdotal only.

Laparoscopic common bile duct exploration: evolution of a new technique Khoo DE, Walsh CJ, Cox MR, Murphy CA, Motson RW Br J Surg (1996) 83: 341–346 Objective: To report and discuss the authors experience with variety of techniques used for exploration of the common bile duct (CBD) at the time of laparoscopic cholecystectomy. Methods: Sixty patients among 638 who underwent laparoscopic cholecystectomy (LC) required CBD exploration as indicted by intraoperative cholangiography or preoperative endoscopic retrograde cholangiopancreatography (ERCP). Laparoscopic CBD exploration was performed using a fiberoptic choledochoscope, either through the cystic duct incision used for cholangiography or through a new incision onto the CBD itself. Stone baskets and balloons were used to retrieve the stones out of the cystic duct or push the stones into the duodenum. CBD incisions were either primarily closed and drained, or closed over a T-tube. In cases of inadequate or unsuccessful clearance of CBD, treatment options included drainage via a cystic duct catheter and subsequent postoperative percutaneous clearance of  CBD, open CBD exploration, or postoperative ERCP. Results: The median time for LC with CBD exploration was 150 min (90–300) compared to 80 min (55–180) for LC alone. The overall success of duct clearance without ERCP or open common bile duct exploration (including those that were cleared postoperatively through the T-tube or the cystic duct tract) was 86% (44 out of 51). Six patients required

postoperative ERCP for clearance of residual stones. One of  these patients died of unrelated causes prior to actual performance of the ERCP. The eight reported complications are as follows: One patient with a cystic duct tube had bile leak, undergoing successful percutaneous drainage; one patient had prolonged drainage from a subhepatic drain; three patients had right hypochondrial pain or pyrexia, requiring prolonged hospital stay; one patient had retained CBD stones presented with cholangitis while awaiting ERCP; one patient had pulmonary infection with prolonged hospitalization; and one patient had urinary retention. Comment: This original article presents an excellent discussion of techniques of CBD exploration and alternatives to this approach. Clearly, there is no consensus in preoperative, operative, and postoperative management of choledocholithiasis. However, as suggested by this report, with improved expertise in laparoscopic CBD exploration, treatment of CBD stones may once again swing from routine pre- or postoperative ERCP back to operative CBD exploration as in the prelaparoscopic era.

Technique for full-thickness muscle closure of  laparoscopic port sites Robertson GSM, Lloyd DM, Kelly MJ, Veitch PS Br J Surg (1996) 83: 383 Objective: To report a technique for full-thickness closure of all laparoscopic trocar site muscle and fascia defects 10 mm or greater in diameter. Methods: Using a combination of a dismantled Veress needle and a straight needle on a suture, a simple technique for full-thickness closure of laparoscopic trocar sites is described. In the presence of at least one 5-mm port, all 10mm-or-larger-diameter trocar sites can be closed expeditiously using the described technique. Comment: Until a universally accepted technique for closure of the muscle and fascia defects at the site of a laparoscopic cannulae is identified, all proposed techniques for such closure should be welcomed and attempted. Without personal experience with the described technique, laparoscopists are encouraged to follow this well-illustrated technique (illustrations are found with the original report) and develop their own opinion of this technique.

Early versus delayed laparoscopic cholecystectomy for treatment of  acute cholecystitis Lo CM, Liu CL, Lai ECS, Fan ST, Wong J Ann Surg (1996) 223(1):37–42 Objective: To examine the outcome of early (within 120 h) laparoscopic cholecystectomy following a diagnosis of  acute cholecystectomy, as compared to that for delayed cholecystectomy.

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Methods: A retrospective review of 52 patients with a diagnosis of acute cholecystitis who ultimately underwent cholecystectomy is presented. Twenty-seven underwent early cholecystectomy and 25 had interval cholecystectomy, all initially attempted laparoscopically. The following variables were noted to be similar within the two groups: age, sex, body weighty, previous biliary symptoms, previous abdominal surgery, duration of acute symptoms, fever, WBC count, total serum bilirubin, alkaline phosphatase, and urea measurements. Results: There were no major operative complications and no mortality in either group. The conversion rate (7.4%) and minor complication rate (22%) were comparable in the two groups. The early group required modifications in operative technique (gallbladder decompression, close suction drainage, use of endoscopic pouches for retrieval of the specimen, and use of additional cannulae) more frequently than the delayed group. Although the operative time (137.2 vs 98.0 min) and postoperative hospital stay (4.6 vs 2.5 days) were higher for the early operative group, the total hospital stay was markedly reduced (6.7 vs 15.1 days). Conclusions: Early laparoscopic cholecystectomy following acute cholecystitis does not increase the risk of complications or conversion to laparotomy. Although the operation is technically more demanding in the early period following acute cholecystitis, it provides the economical advantages of reduced hospital stay as compared to that for delayed cholecystectomy. Comment: This retrospective review of a small sample size illustrates the economic advantages of early cholecystectomy for acute cholecystitis. It, however, fails to point out the clinical advantages, to the patient, following early removal of a diseased and nonfunctioning or stone-harboring gallbladder. It is also important to note that for elderly or debilitated patients, prolonged operative time is less desirable and, therefore, early cholecystectomy in this select population may be less advisable.

Mechanisms of gastric and esophageal perforations during laparoscopic Nissen fundoplication Schauer PR, Meyers WC, Eubanks S, Norem RF, Franklin M, Pappas TN Ann Surg (1996) 223(1):37–42 Objective: To determine the mechanisms for gastric and esophageal injuries during laparoscopic Nissen fundoplication (LNF). Methods: A review of 17 gastric and esophageal perforations following LNF is presented. For each perforation, details including the mechanism of injury, surgeon’s experience, diagnosis, treatment, and the ultimate outcome of the injury are reviewed. Results: The majority of injuries occurred within the first 10 LNFs performed by each individual surgeon. Three mechanisms accounted for all of the 17 injuries: improper retroesophageal dissection (10), passage of the esophageal dilator or nasogastric tube (five), and suture pullthrough

(two). When diagnosed at surgery, repair of perforation was mostly accomplished by primary closure and wrap to include the repair. Five perforations were repaired following conversion to laparotomy, and another required thoracotomy for repair of a thoracic esophageal perforation. Delayed diagnosis of perforation in six patients adversely affected their outcome (including one death in the entire series). Conclusions: Gastric and esophageal perforation during LNF are serious complications with significant associated morbidity and mortality. A full understanding of the detailed anatomy of the gastroesophageal region and awareness of the mechanisms of perforation may help reduce the incidence of these complications. Comments: The increase in morbidity and mortality associated with the delayed diagnosis of gastric or esophageal perforations may justify the use of routine contrast esophagogastrography following laparoscopic Nissen fundoplication.

Diaphragmatic herniation after penetrating trauma Degiannis E, Levy RD, Sofianos C, Potokar T, Florizoone MGC, Saadia R Br J Surg (1996) 83:88–91 Objective: To review one trauma center’s experience with traumatic diaphragmatic hernias and the risk factors associated with mortality in this patient population. Methods: A retrospective review of the outcome of 45 diaphragmatic herniations during a 7-year period (between 1987 and 1994) is presented. Results: All herniations were through the left hemidiaphragm. In 29, the diagnosis was made early (during the initial hospitalization), and in 16 during a subsequent admission (delayed presentation). Within these two groups, the mortality rates were 3% and 25%, respectively. The presence of gangrenous or perforated abdominal viscera in the thoracic cavity was the single most common and complicating factor among the fatalities. Conclusions: The early diagnosis of traumatic diaphragmatic injuries is paramount to the salvage of otherwise survivable patients with penetrating thoracoabdominal injuries. Comment: With trauma surgeons’ evergrowing facility in laparoscopic surgery, diagnostic laparoscopy may become the gold standard in the management of patients with penetrating thoracoabdominal injuries who have no other indications for immediate laparotomy.

Factors affecting conversion of laparoscopic cholecystectomy to open surgery Liu CL, Fan ST, Lai ECS, Lo CM, Chu KM Arch Surg (1996) 131:98–101 Objective: To identify risk factors predictive of conversion of a laparoscopic cholecystectomy to a laparotomy.

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Methods: A retrospective review of 500 patients operated on between 1991 and 1994 is presented. Demographic, ultrasonographic, and operative data are examined. Results: The following factors significantly increased the need for conversion to laparotomy: age over 65, obesity, acute cholecystitis followed by interval elective cholecystectomy, ultrasonographic finding of thickened gallbladder wall, procedures performed during the learning curve (for this series), and surgery performed by senior surgeons (in this group of five surgeons). Sex, previous lower abdominal surgery, history of acute pancreatitis or cholangitis, impaired liver function on presentation, or emergency laparoscopic cholecystectomy for acute cholecystitis did not significantly increase the rate of conversion to laparotomy. Conclusions: Knowledge of factors contributing to the incidence of conversion to laparotomy during laparoscopic cholecystectomy may help to better prepare the patient, the operating room schedule, and the duration of convalescence. Comment: The conclusions from this retrospective study are most appropriate. In 1996, almost every cholecystectomy candidate deserves a laparoscopic attempt. However, the knowledge of risk factors for conversion to laparotomy allow for a more thorough discussion between the surgeon and the patient and better mental preparation for not only the patient, but the operating room staff.

Surgical resection for small hepatocellular carcinoma Nagashima I, Hamada C, Naruse K, Osada T, Nagao T, Kawano N, Muto T Surgery (1996) 119:40–45 Objective: To investigate the clinicopathologic determinants of the long-term prognosis for surgically resected solitary small hepatocellular carcinoma (s-sHCC; 2 cm or less in diameter). Methods: A retrospective review of 44 survivors of partial hepatectomy for s-sHCC between 1977 and 1992 is reported. There were six others who died perioperatively. The eight clinicopathologic features examined are as follows: presence of vascular invasion, capsular formation, the distance of free surgical margin, serum alpha-fetoprotein level, positive hepatitis B surface antigen, preoperative transarterial embolization, Child’s classification, and complicated liver function. Results: Complicated liver function (a scoring system which is based on serum albumin, indocyanine green retention, prothrombin time, platelet count, and preoperative presence or absence of ascites) was the only significant factor related to survival and disease-free survival rates.

Conclusions: A good hepatic reserve is an important indicator of prognosis following surgical resection of solitary small hepatocellular carcinoma. In the absence of adequate hepatic reserve, liver transplantation must be considered even if curative resection is feasible. Comment: This study further emphasizes the significance of hepatic reserve in the ultimate prognosis for curative resection of even the smallest primary tumors of the liver.

A comparison of the strength of knots tied by hand and at laparoscopy Kadirkamanathan SS, Shelton JC J Am Coll Surg (1996) 182:46–54 Objective: To compare the strength of laparoscopically tied knots with those tied by hand as well as to assess the strength of knots tied as a function of the suture material and the type of knot. Methods: Eight types of suture material (Nylon, PDS, PTFE, Vicryl, Ticron, Ethibond, Nurolon, silk), and eight types of knots that are commonly used were examined. The knots were tied in fresh postmortem human stomachs. A mechanical device was used to examine the force necessary to undo or break the knots. Results: For most monofilament threads, at least four half  hitches were necessary to tie a secure, nonslipping hand-tie knot. For Vicryl (polyglactin 910), Ticron (braided polyester), silk, and PDS (polydiaxone), three half hitches were adequate. For laparoscopically tied knots, the variance for the strength of knots was generally greater. For most laparoscopically tied knots, the strength was less than that for the hand-tied counterparts. However, an additional throw typically increased the strength of the laparoscopically tied knots. In most instances, four half hitches were necessary to secure a laparoscopic knot. The Roeder knot applied extracorporeally was significantly less secure than four half  hitches. Conclusions: The laparoscopically tied knots may not be as secure as their hand-tied counterparts. The type of suture material should be considered as an indicator of the optimal knot configuration. Comment: Considering the various violations of the common practice of knot tying during laparoscopic surgery, it is not surprising that a study designed to examine the strength of the knots would favor hand-tied knots. It therefore behooves all laparoscopists to become expert in intracorporeal knot tying and to consider extracorporeal alternative other than the Roeder knot.

Reviewers for this issue: J. Hunter, V. Shryani, J. M. Saˆckier

Surg Endosc (1997) 11: 74–76

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Thoracoscopic surgery combined with a supraclavicular approach for removing superior mediastinal tumor A. Akashi, S. Ohashi, Y. Yoden, H. Kanno, K. Tei, H. Sasaoka, Y. Sakamaki, T. Katsura, M. Nishino, H. S. M. Manzurul Department of Surgery, Takarazuka City Hospital, 4-5-1 Kohama, Takarazuka, Hyogo 665, Japan Received: 12 December 1995/Accepted: 19 March 1996

Abstract. This report introduces our new technique of thoracoscopic surgery combined with a supraclavicular approach for removing superior mediastinal tumor. A 68-yearold woman noticed a tumor palpable in the left supraclavicular fossa. The patient had no pain around the neck and shoulder. A radio-opaque shadow 6 cm in diameter was detected in her left apical lung field on chest roentgenogram. Chest CT and MRI showed that the tumor was located in the superior mediastinum, extending up to the thoracic inlet, and there was no invasion of the surroundings. At first, a thoracoscopic examination was performed to assess the possibility of the excision. After dissecting the tumor from the mediastinal tissue and the first costovertebrae as far as possible by thoracoscopic surgery, a supraclavicular approach was used to enter the thoracic cavity. Complete resection of the tumor was successfully performed by thoracoscopic surgery combined with a supraclavicular approach. The tumor was removed in a plastic bag through the supraclavicular defect. Postoperative histopathology revealed that the tumor was a benign neurogenic one. A satisfactory follow-up of 5 postoperative days was observed without any complications, and the patient was discharged. The procedure was safe, easy, and minimally invasive to perform. Moreover, the supraclavicular approach could be used to add trocar port if needed. Key words: Thoracoscopic surgery — Supraclavicular approach — Mediastinal tumor

The recent popularity of thoracoscopic surgery made possible by dramatic improvements in endoscopic surgical instrumentation and techniques has resulted in renewed interest in thoracoscopy [3, 4]. A supraclavicular approach has been recommended for diagnosis of apical lung and superior

Correspondence to: A. Akashi

mediastinal lesions [2]. We describe a new technique of  thoracoscopic surgery combined with a supraclavicular approach for removing superior mediastinal tumor. This technique allows an excellent and a satisfactory extirpation of  the tumor with minimum invasion and minimum discomfort to the patient.

Case report A 68-year-old woman noticed a tumor palpable in the left supraclavicular fossa but had no pain around the neck and shoulder. A radio-opaque shadow 6 cm in diameter was detected in her left apical lung field on chest roentgenogram (Fig. 1). Chest CT and MRI showed that the tumor was located at the thoracic inlet as well as in the superior mediastinum, but it was not found to invade the structures in the thoracic inlet including the subclavian vessels, adjacent ribs, and vertebrae. On the basis of the tumor location as well as the characteristic shadow of the tumor on chest X-ray, computed tomography (CT) and magnetic resonance imaging (MRI, Fig. 2), the patient was clinically considered to be a case of neurogenic tumor.

Operative technique Operation was performed under general anesthesia. The patient was positioned in a supine decubitus with a small roll under the scapula and shoulder. The left chest was elevated 30° from the supine position and the left extremity was also elevated 30° from the table and the body. The neck was excessively extended, and the head was turned away from the left side. The entire left chest, shoulder, axilla, and lower neck were prepared in a sterile field. Four trocar ports for thoracoscopic procedures were applied in this patient (Fig. 3). On the third intercostal space, in the midclavicular line, a 10-mm blunt-tip viewing thoracoscope with attached video camera was introduced through the 10-mm trocar cannula for the camera port was inserted intercostally. A 10-mm viewing thoracoscope with attached video camera was introduced through the 10-mm cannula and the pleural cavity was inspected thoroughly. Three additional trocars for surgical instruments, each 5 mm in diameter, were placed in the thoracic cavity through the third and fourth intercostal space; two were placed in the anterior axillary line and the third in the midaxillary line. At first, a thoracoscopic examination was performed to assess the possibility of an thoracoscopic excision. Thoracoscopic findings revealed that the tumor originated from the sympathetic trunk, and the upper part of the tumor was located in the superior section of the first costovertebral gutter. Then a microdissector was introduced through the cannula in the third

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Fig. 1. Chest roentogenogram shows the tumor (arrow) located in the apical lung field. Fig. 2. Chest magnetic resonance imaging (MRI) shows the tumor (arrow) located in the superior mediastinum extending up to the thoracic inlet.

intercostal space. The parietal pleura was grasped at the level of the first costal cartilage. A hook cautery probe was introduced through the other cannula in the third intercostal space. After carefully dissecting the tumor from the mediastinal tissue and the first costovertebrae as far as possible by thoracoscopic technique, the tumor was found to be located at the thoracic inlet area adjacent to the subclavian artery, vein, and the left common carotid artery. So a supraclavicular approach was used to assist and complete the tumor resection. A supraclavicular skin incision 5 cm long was made 1 cm above and parallel to the left clavicle. The clavicular end of the sternocleidomastoid and the omohyoid muscle were divided. The phrenic nerve in fascial covering of the anterior scalene muscle was identified and retracted medially. The anterior scalene muscle was divided close to the clavicle. The subclavian vessels were retracted caudally so that the tumor could be reached. The complete resection of the tumor was successfully performed by tho-

Fig. 3. Schema of thoracoscopic surgery with supraclavicular approach. Supraclavicular incision and four trocar ports for thoracoscopic and three other instruments. Fig. 4. A combination of thoracoscopic surgery and fine manipulation through supraclavicular approach for dissection of the tumor. F: finger, T: tumor, SCA: subclavian artery.

racoscopic technique assisted by fine manipulation through supraclavicular approach (Fig. 4). The tumor was extracted in a plastic bag through the supraclavicular incision. The left lung was expanded under positive pressure and the four cannulas were removed. A chest tube was inserted for drainage. The neck incision was then closed. A satisfactory follow-up of 5 postoperative days were observed without any complication and the patient was discharged.

Discussion Thoracoscopic surgery is gaining in popularity day by day as a standard method for treating lesions in the thoracic

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cavity [3]. Exploratory thoracotomy through the supraclavicular area has so far been used to obtain tissue for the diagnosis of apical lung and superior mediastinal lesions [2]. In a previous study [1], we described our new thoracoscopic approach to performing parasternal lymph node dissection for advanced breast cancer, which seems to be a less invasive technique as compared with the classical operation. In the present study, we applied our original thoracoscopic procedure and additional finger manipulation through supraclavicular incision for easy dissection and removal of the tumor. This additional approach has advantages: (1) A large solid tumor located in the upper part of the thoracic cavity can easily be mobilized and taken out of the thoracic cavity, and (2) the supraclavicular approach can be used to add a trocar port for thoracoscopic surgery. In conclusion, the technique of thoracoscopic removal of the upper mediastinal tumor assisted with a fine manipu-

lation through supraclavicular approach allows an excellent and a satisfactory extirpation of the tumor with minimum invasion and minimum discomfort to the patient.

References 1. Akashi A, Ohashi S, Yoden Y, Kanno H, Koh M, Tei K (1994) Thoracoscopic approach of para-sternal lymph node dissection for advanced breast cancer (Abstr). Surg Endosc 8: 631 2. Dart CH Jr, Braitman HE, Larlarb S (1979) Supraclavicular thoracotomy for diagnosis of apical lung and superior mediastinal lesions. Ann Thorac Surg 28: 90–93 3. Lanreneau RJ, Hazelrigg SR, Mack MJ, Keenan RJ, Ferson PF (1994) Video-assisted thoracic surgery for diseases within the mediastinum. In: Shields TW (ed) General thoracic surgery. Williams & Wilkins, Philadelphia, pp 1810–1816 4. Sugarbaker DJ (1993) Thoracoscopy in the management of anterior mediastinal masses. Ann Thorac Surg 56: 653–656

Surg Endosc (1997) 11: 42–44

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Postoperative drowsiness and emetic sequelae correlate to total amount of carbon dioxide used during laparoscopic cholecystectomy A.-M. Koivusalo,1 I. Kellokumpu, 2 L. Lindgren1 1

Department of Anaesthesia, IV Department of Surgery, Helsinki University Hospital, University of Helsinki, Kasarmikatu 11-13, FIN-00130, Helsinki, Finland 2 Department of Surgery, IV Department of Surgery, Helsinki University Hospital, University of Helsinki, Kasarmikatu 11-13, FIN-00130, Helsinki, Finland Received: 11 January 1996/Accepted: 29 May 1996

Abstract  Background: After laparoscopy with carbon dioxide (CO2) insufflation early postoperative recovery is often complicated with drowsiness and postoperative nausea and vomiting (PONV).  Methods: 25 ASA I − II patients undergoing elective laparoscopic cholecystectomy under standardized anaesthesia were studied in a randomized, prospective study. The conventional CO2 pneumoperitoneum was compared with the mechanical abdominal wall lift (AWL) method with minimal CO2 insufflation with special reference to postoperative recovery.  Results: Postoperative drowsiness was of a significantly longer duration with the conventional method (p < 0.001) compared with the AWL technique. There was a positive correlation with the total amount of CO2 used and the duration of drowsiness (r 0.75, p < 0.01). PONV was seen significantly more often in patients with CO 2 insufflation of  more than 121 (p < 0.05). Conclusions: Avoiding excessive CO 2 is beneficial for smoother and more uneventful recovery after laparoscopic cholecystectomy. Key words: Carbon dioxide — Laparoscopic cholecystectomy — Postoperative drowsiness

Laparoscopic cholecystectomy with carbon dioxide (CO2) insufflation is the treatment of choice for symptomatic gallstones [10]. We have, however, a clinical impression that in the early postoperative period the patients are often very drowsy and sometimes restless. They can also suffer from

Correspondence to: A.-M. Koivusalo

postoperative nausea and vomiting (PONV). These sequelae may be attributed to CO2 used during laparoscopic cholecystectomy. We, therefore, have conducted a randomized study in 25 ASA I–II patients undergoing elective laparoscopic cholecystectomy with various amounts of CO2. The Ethics Committee approval and patient informed consent were obtained. The patients in one group underwent a standard laparoscopy with CO2 insufflation to achieve a conventional pressure pneumoperitoneum (intra-abdominal pressure between 12 and 15 mmHg) (CPP group). In the other group we used an abdominal wall-lift method (AWL group) (a modification of the method first described by Cuschieri) [2]. In AWL a small amount of CO2 (less than 3 l) was insufflated into the abdominal cavity. Thereafter the Hoffman’s trocar was introduced through two small stab wounds across and beneath the rectus abdominis muscles and falciformic ligament under vision. The trocar was then attached with a cotton ribbon to a horizontal bar placed at the level of the processus xiphoideus 40 cm above the chest (Fig. 1). With this technique the anterior part of the abdomen could be elevated 10–15 cm upward. If the surgeon was not satisfied with the view, he was able to insufflate additional CO2 to achieve an adequate operation field. Anesthesia was standardized in all patients with thiopentone, vecuronium, and isoflurane at an end-tidal (etIso) concentration of 1 MAC (minimal alveolar concentration). No nitrous oxide was used. The minute volume of ventilation was increased if  needed in order to keep the end-tidal CO 2 concentration between 4.5 and 4.8%. Analgesia was accomplished with fentanyl 0.2 mg kg−1 h−1. All patients were extubated at the same etIso concentration of 0.2%. The patient stayed 3 h in the recovery room. During that period the postoperative drowsiness was scored as follows: 0 fully awake, 1 sedated, but responding to commands, 2 hardly responding to commands. Score 2 was regarded drowsiness. Duration of drowsiness (min) was re-

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Fig. 1. Abdominal wall-lift method.

corded. Occurrence of vomiting (PONV) during the first 24 h was registered. Correlation between the duration of drowsiness and the total amount of CO2 was drawn. Other data were analyzed with analysis of variance (ANOVA). Data are expressed as mean (±SD). The two groups were comparable in age, height, weight, ASA physical status, gender, and duration of operation. Two patients in each group suffered from seasickness. The total amount of CO2 used was 40 (23) l with CPP. With the AWL method 9 (7) l of CO2 was needed ( p < 0.001). Drowsiness lasted 96 (48) min after CPP and 15 (30) min after AWL method ( p < 0.001). There was a positive correlation between the total amount of CO 2 used and the duration of drowsiness (r  0.75, p < 0.01) (Fig. 2). One patient after 46 l of CO 2 was so restless that he needed a fence for his bed. One patient with AWL method (8%) and a total of six (58%) patients with CPP suffered from vomiting during the first 24 h ( p < 0.05). The total amount of CO2 used was 44 (33) l in the seven patients with PONV and 18 (14) l in those patients without ( p < 0.001). If the total amount of CO2 exceeded 12 l the incidence of PONV increased significantly ( p < 0.05). All patients were fully recovered and PONV free on the 1st postoperative day. We have demonstrated that the less CO2 used to create the pneumoperitoneum the shorter and more comfortable the early postoperative recovery is. We presume that CO 2 is responsible for the prolonged recovery and emetic symptoms. The total amount of CO2 of 12 l seems to be crucial for development of PONV. CO2 has many disadvantages. It has several central nervous system effects. CO2 is thought to exert an inert gas narcotic effect in accord with its physical properties, which are similar to those seen with nitrous oxide [7]. For example, when rats are exposed to 100% CO 2 for only 1 min they loose consciousness [3]. There is evidence that CO2 bubbles can reach the right side of the heart during pneumoperitoneum [4]. Large emboli are able to escape from the venous side to arterial circulation through the lungs [13]. The prolonged drowsiness may also possibly be due to small CO2 bubbles reaching cerebral circulation. CO 2 also has dilatory effects on cerebral vessels, and therefore it increases intracranial pressure (ICP). Elevated ICP is known

Fig. 2. The correlation between the total amount of CO2 used during the laparoscopic cholecystectomy and postoperative drowsiness. r  0.75, p < 0.01. ᭹ conventional pneumoperitoneum group, ᭺ abdominal wall lift group.

to cause nausea and vomiting [1]. This might be the reason for PONV also in our study. The incidence of PONV of  60% after laparoscopic surgery has been recently reported also by others [8]. Elevated catecholamine levels have been seen as a response to CO2 pneumoperitoneum [6]. Pulse rate and blood pressure are consequently increased. This is deleterious to patients with restricted coronary circulation [11]. Furthermore, CO2 is reported to have caused serious gas emboli [5, 9], exposing the patient to a life-threatening situation. In addition, CO2, as a volatile acid, can lead to respiratory acidosis during prolonged procedures [12]. In conclusion, to guarantee a safe operation and a smooth, uneventful recovery after laparoscopic cholecystectomy, avoiding excessive CO2 may be beneficial. Laparoscopic cholecystectomy can hopefully be performed as daycase surgery in the future. Minimal amounts of CO2 or totally gasless methods would constitute one step toward this goal.

References 1. Andrews PLR (1992) Physiology of nausea and vomiting. Br J Anaesth 69 (Suppl 1): 2S–19S 2. Banting S, Shimi S, van der Velpen G, Cuschieri A (1993) Abdominal wall lift. Surg Endosc 7: 57–59 3. Berger-Sweeney J, Berger UV, Sharma M, Paul CA (1994) Effects of  carbon dioxide-induced anesthesia on cholinergic parameters in rat brain. Lab Anim Sci 44: 369–371 4. Derouin M, Couture P, Boureault D, Girard D, Gravel D (1996) Detection of gas embolism by transesophageal echocardiography during laparoscopic cholecystectomy. Anesth Analg 82: 119–124 5. Diakum TA (1991) Carbon dioxide emboli: successful resuscitation with cardiopulmonary bypass. Anesthesiology 74: 1151–1153 6. Joris L, Lamy M (1993) Neuroendocrine changes during pneumoperitoneum for laparoscopic cholecystectomy. Br J Anaesth 70: A 33 7. Leake C, Waters R (1928) The anesthetic properties of carbon dioxide. J Pharmacol Exp Ther 33: 280 8. Koivuranta M, La¨a¨ra¨ E, Ryha¨nen P (1996) Antiemetic efficacy of 

44 prophylactic ondansetron in laparoscopic cholecystectomy. Anaesthesia 51: 52–55 9. McGrath BJ, Zimmerman JE, Williams JF, Parmet J (1989) Carbon dioxide embolism treated with hyperbaric oxygen. Can J Anaesth 36: 586–589 10. McMalcon AJ, Russell IT, Baxter JN, Ross S, Andersson JR, Morran CG, Sunderland G, Galloway D, Ramsay G, O’Dwyer PJ (1994) Laparoscopic versus minilaparotomy cholecystectomy: a randomized trial. Lancet 343: 135–138

11. Nachlas M, Abrams S, Goldberg M (1961) The influence of arteriosclerotic heart disease on surgical risk. Am J Surg 101: 447– 455 12. Seed RF, Shakespeare TF, Muldoon MJ (1970) Carbon dioxide homeostasis during anaesthesia for laparoscopy. Anaesthesia 25: 223– 231 13. Vik A, Jenssen BM, Brubakk AO (1991) Effect of aminophylline on transpulmonary passage of venous air emboli in pigs. J Appl Physiol 71: 1780–1786

Surgical Endoscopy

 News and notices

Surg Endosc (1997) 11: 87–89

New Address for the European Association for Endoscopic Surgery (E.A.E.S.) Effective January 1, 1996, the new correspondence, telephone, and fax numbers of the E.A.E.S. office are: E.A.E.S. Office, c/o Mrs. Ria Palmen De Run 5601 5504 DK Veldhoven The Netherlands Tel: 31 40 255 42 68 Fax: 31 40 254 97 77

Fellowship in Minimally Invasive Surgery George Washington Medical Center Washington, DC USA A one-year fellowship is being offered at the George Washington University Medical Center. Interested candidates will be exposed to a broad range of endosurgical Education and Research Center. Active participation in clinical and basic science research projects is also encouraged. For further information, please contact: Carole Smith 202-994-8425

© Springer-Verlag New York Inc. 1997

Advanced Endoscopic Skills Surgical Skills Unit University of Dundee Scotland, UK Each month Professor Cuschieri Surgical Skills Unit offers a 4 1 ⁄ 2 day course in Advanced Endoscopic Skills. The course is intensely practical with ‘‘hands on’’ experience on a range of simulated models. The program is designed for experienced endoscopic surgeons and covers advanced dissection techniques, extracorporeal knotting techniques, needle control, suturing, internal tying technique, stapling, and anastomotic technique. Individual workstations and a maximum course number of 10 participants allows for personal tuition. The unit offers an extensive collection of surgical videos and the latest books and publications on endoscopic surgery. In addition, participating surgeons will have the opportunity to see live advanced laparoscopic and/or thoracoscopic procedures conducted by Professor Cuschieri and his team. The course is endorsed by SAGES. Course fee including lunch and course materials is $1850. For further details and a brochure please contact: Julie Struthers, Unit Co-ordinator Surgical Skills Unit Ninewells Hospital and Medical School Dundee DD1 9SY Tel: +44 382 645857 Fax: +44 382 646042

or, send curriculum vitae to: Dr. Jonathan M. Sackier Director of Endosurgical Education and Research George Washington University Medical Center Department of Surgery 2150 Pennsylvania Avenue, N.W. 6B-417 Washington, DC 20037, USA

Essentials of Laparoscopic Surgery Surgical Skills Unit University of Dundee Scotland, UK Under the direction of Professor A. Cuscheri the Surgical Skills Unit is offering a three-day practical course designed for surgeons who wish to undertake the procedures such as laparoscopic cholecystectomy. This intensely practical program develops the necessary operating skills, emphasizes safe practice, and highlights the common pitfalls and difficulties encountered when starting out. Each workshop has a maximum of 18 participants who will learn both camera and instrument-manipulation skills in a purpose-built skills laboratory. During the course there is a live demonstration of a laparoscopic cholecystectomy. The unit has a large library of operative videos edited by Professor Cuschieri, and the latest books on endoscopic surgery are on display in our Resource area. Course fee including lunch and course materials is $860. For further details and a brochure please contact: Julie Struthers, Unit Co-ordinator Surgical Skills Unit Ninewells Hospital and Medical School Dundee DD1 9SY Tel: +44 382 645857 Fax: +44 382 646042

The Practical Aspects of Laparoscopic Fundoplication Surgical Skills Unit University of Dundee Scotland, UK A three-day course, led by Professor Cuschieri, designed for experienced laparoscopists wishing to include fundoplication in their practice. The course covers the technical details of total and partial fundoplication using small group format and personal tuition on detailed simulated models. There will be an opportunity to observe one of these procedures live during the course. Maximum course number is six. Course fee including lunch is $1850. For further details and a brochure please contact: Julie Struthers, Unit Co-ordinator Surgical Skills Unit Ninewells Hospital and Medical School Dundee DD1 9SY Tel: +44 382 645857 Fax: +44 382 646042

Courses at George Washington University Endosurgical Educational and Research Center George Washington University Endosurgical Educational and Research Center is proud to offer a wide range of surgical endoscopy courses. These courses include advanced laparoscopic skills such as Nissen fundoplication, colon resection, common bile duct exploration, suturing, as well as

88 subspecialty courses. Individual surgeons needs can be met with private tuition. The Washington D.C. area is a marvelous destination to visit for recreational pursuits which can be arranged by the facility to suit your personal agenda. For further details please contact: Carole Smith: Department of Surgery 2150 Pennsylvania Avenue NW 6B Washington, DC 20037, USA Tel: (202) 994-8425

Courses at the Royal Adelaide Centre for Endoscopic Surgery Basic and Advanced Laparoscopic Skills Courses are conducted by the Royal Adelaide Centre for Endoscopic Surgery on a regular basis. The courses are limited to six places to maximize skill development and tuition. Basic courses are conducted over two days for trainees and surgeons seeking an introduction to laparoscopic cholecystectomy. Animal viscera in simulators is used to develop practical skills. Advanced courses are conducted over four days for surgeons already experienced in laparoscopic cholecystectomy who wish to undertake more advanced procedures. A wide range of procedures are included, although practical sessions can be tailored to one or two procedures at the participants request. Practical skills are developed using training simulators and anaesthetised pigs. Course fees: $A300 ($US225) for the basic course and $A1,600 ($US1,200) for the advanced course.

egory 1 of the Physician’s Recognition Award of the American Medical Association. These programs are also endorsed by the Society of Gastrointestinal Endoscopic Surgeons (SAGES). For further information, please contact: Wanda Toy, Program Administrator Microsurgery & Operative Endoscopy Training (MOET) Institute 153 States Street San Francisco, CA 94114, USA Tel: (415) 626-3400 Fax: (415) 626-3444

First Congress of the Dutch Society of  Endoscopic Surgery January 23–24, 1997 Rotterdam, The Netherlands The Congress will meet at the University Hospital Dijkzigt Rotterdam, The Netherlands. For further information, please contact: Office for Postgraduate Medical Education Erasmus University Rotterdam Mrs. Y.K.S. Schunselaar P.O. Box 1738 3000 DR Rotterdam Tel: +31 (0) 10 408 7881 Fax: +31 (0) 10 436 7271 e-mail: [email protected]

For further details and brochure, please contact: Dr. D. I. Watson or Professor G. G. Jamieson The Royal Adelaide Centre for Endoscopic Surgery Department of Surgery Royal Adelaide Hospital Adelaide SA 5000 Australia Tel: +61 8 224 5516 Fax: +61 8 232 3471

Advanced Laparoscopic Suturing and Surgical Skills Courses MOET Institute San Francisco, CA, USA This intensive hands-on training program is intended to help the surgeon develop proficiency in the essential laparoscopic surgical techniques. A sequence of progressively challenging exercises has been designed to enable the surgeon to improve his or her laparoscopic dexterity, efficiency, and creativity. Exact and meticulous technique is emphasized so that the surgeon can apply these skills with confidence. Personal instruction is provided by Zoltan Szabo, Ph.D., F.I.C.S., Director of the MOET Institute, and surgeons are allowed to progress their own pace. Each participant has sole use of a laparoscopic training station equipped with high-quality clinical laparoscopic equipment and instrumentation. Inanimate, animal tissue, and optional live animal models are utilized. Features of these program include: fluently choreographed instrument movements; economy of movement and ‘‘flawless’’ technique; needle and suture handling skills (2-0 to 7-0); precision suturing, knotting, ligature, and anastomosis techniques; atraumatic, hemostatic tissue handling and dissection; optimal angles of approach (coaxial alignment of setup and geometry of port positioning); laparoscopic surgical strategy, technical nuances, and troubleshooting; visual perception problems and solutions; magnified eye-hand coordination; and two-handed (ambidextrous) technique. Courses are offered year-round by individual arrangement. The MOET Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians and designates these CME activities for 20–40 credit hours in Cat-

IIIrd European Workshop on Digestive Surgery March 13–14, 1997 Brussels, Belgium The IIIrd European Workshop on Digestive Surgery is focused on live operative demonstrations performed and narrated by European experts. Panel discussions, quizzes, and selected communications will take place during the sessions. The aims are to confront alternative procedures and to provide young surgeons with an overview of selected fields. Topics will be: functional anorectal surgery, proctology, colorectal surgery, and updates in laparoscopic surgery. Course direction: J. J. Houben, MD. For further information, please contact: Administrative Secretariat Conference Services s.a. Avenue de l’Observatoire 3, bte 17 B-1180 Brussels, Belgium Tel: +32 2 375 16 48 Fax: +32 2 375 32 99

First International Baltic Conference of Videosurgery of  the Viscerosynthesis Section of the Association of  Polish Surgeons April 24–27, 1997 Gdansk, Poland For further information, please contact: Organizing Secretariat Second Department of Surgery Medical University of Gdansk  1 Prof. Z Kieturakisa Street 80-742 Gdansk, Poland Tel/Fax: (0 048 58) 31 87 75

89

9th International Meeting Society for Minimally Invasive Therapy July 14–16, 1997 Kyoto, Japan Scientific program to include: Plenary, Parallel, Poster, and Video sessions. Host Chairman: Professor Osamu Yoshida, Department of Urology, Kyoto University, 54 Shogoin Kawahara-sho, Sakyo, Kyoto 606, Japan. Phone: +81 75 751-3328, Fax: +81 75 751-3740. This meeting coincides with the Gion Festival in Kyoto, one of the greatest festivals in Japan. For further information, please contact: Secretariat of SMIT 9th Annual International Meeting c/o Academic Conference Planning 383 Murakami-cho Fushimika, Kyoto 612 Japan Tel: +81 75 611-2008 Fax: +81 75 603-3816

6th World Congress of Endoscopy Surgery ‘‘Roma 98’’ 6th International Congress of European Association for Endoscopic Surgery June 3–6, 1998 Rome, Italy The program will include: the latest, original high quality research; symposia; plenary lectures; abstract presentations (video, oral, and posters); EAES and SAGES postgraduate courses, OMED postgraduate course on therapeutic endoscopy; working team reports; educational center and learning corner; meeting of the International Society of Nurses and Associates; original and non original scientific reports; and a world expo of new technology in surgery. For further information, please contact: Congress Secretariat: Studio EGA Viale Tiziano, 19 00196 Rome, Italy Tel: +39 6 322-1806 Fax: +39 6 324-0143

Surg Endosc (1997) 11: 32–35

Surgical Endoscopy © Springer-Verlag New York Inc. 1997

Laparoscopic ventral and incisional hernioplasty M. D. Holzman, C. M. Purut, K. Reintgen, S. Eubanks, T. N. Pappas Box 3479, Duke University Medical Center, Department of Surgery, Durham, NC 27710, USA Received: 8 April 1996/Accepted: 6 June 1996

Abstract.  Background: While the first laparoscopic ventral hernia repair was reported in 1992, there have been no studies comparing laparoscopic to conventional ventral herniorrhaphy.  Methods: Twenty-one ventral hernias repaired laparoscopically are compared to a similar group of 16 patients undergoing traditional open repair during a 2-year period. Operative and hospital courses along with outcomes and cost analysis are analyzed.  Results: There was no statistical difference between groups in number of previous abdominal operations, prior hernia repairs, and comorbidities. Patients undergoing open repair were older with larger fascial defects. Open repairs had a shorter operative time as compared to the laparoscopic group, but statistically longer postoperative stays and costs. Postoperative complications occurred in 31% of the open group and 23% of the laparoscopic group. There were two recurrences in each group. Conclusions: Laparoscopic herniorrhaphy is as safe and effective as the traditional open technique with shorter length of stay and decreased hospital costs. Key words: Laparoscopy — Incisional herniorrhaphy — Hernia — Mesh

The laparoscopic approach to inguinal herniorrhaphy first reported by Ger [7] had led to a variety of laparoscopic hernia repairs. The first laparoscopic incisional herniorrhaphy publication appeared in 1992 [9]. Since that time there have been numerous case reports in the literature [2, 4, 5, 8, 15] but comparative studies have not been presented. This study retrospectively reviewed our recent experiences with laparoscopic incisional herniorrhaphy and compares them to our patients who underwent a traditional open repair during the same time period. Operative and hospital courses as well as patient outcome and cost were analyzed in order to help

Correspondence to: T. Pappas

better define the role of laparoscopic repair of incisional and ventral hernias.

Materials and methods We retrospectively reviewed 37 incisional and ventral herniorrhaphies performed by the senior author between January 1993 and October 1995. All patients encountered during the review period with fascial defects greater than 25 cm 2 were included in the series (i.e., small defects such as umbilical hernias were excluded). Sixteen traditional open repairs were performed on 16 patients, and 21 laparoscopic repairs on 20 patients with one conversion to an open repair. In the open group the mean age was 60.4 ± 10.2 years with an average 2.8 ± 1.8 comorbidities which would directly effect wound healing or tension on the abdominal wall (Table 1). There were an average of 3.6 ± 2.6 previous abdominal operations; four patients had had prior repair of  their incisional hernias (range 1–9). In the laparoscopic group the mean age was 51.9 ± 13.5 years—an average of 3 ± 1.5 comorbidities which would directly effect wound healing or tension on the abdominal wall. On average there were 2.3 ± 1.4 previous abdominal operations; eight patients had had prior open repair of their incisional hernias (range 1–4) (Table 2). Operations in both groups were performed under general anesthesia on an elective basis. Open repairs were performed one of three ways. The smaller hernias were closed primarily with simple interrupted nonabsorbable suture as described by Skandalakis [17]. Larger defects requiring prosthetic material were repaired either with an inlaid prosthesis [18] or a modified Gallie repair [10]. Laparoscopic repairs were performed by lateral and inferior (when possible) trocar placement. Specific port placement was dependent on the location and size of the hernia. Intra-abdominal adhesions were taken down with sharp and blunt dissection. No attempt was made to resect the hernia sac. With the hernia completely identified and a minimum of 4 cm of  healthy tissue surrounding the defect on the posterior aspect of the anterior abdominal wall, a piece of Marlex mesh was secured. The mesh was attached to the abdominal wall using a standard laparoscopic hernia stapler. Attempts to cover the mesh with omentum were made when possible. This was accomplished either by simple interposition of the omentum between the exposed mesh and underlying bowel or by actually stapling the omentum to the abdominal wall to cover the mesh. The mesh was not covered by peritoneum, nor was a composite prosthesis utilized. Hospital charts were reviewed for operative times, complications, and costs. Postoperative course was determined by review of hospital and clinic charts. Follow-up was conducted by phone interview to determine longterm complications and patient satisfaction. Four patients were lost to follow-up, two from each group. Statistical analysis was performed using unpaired Student’s t -tests of  unequal variance.

33 Table 2. Patient demographics a

Table 1. Comorbidities which adversely effect hernia repair

•Obesity •Age (>70) •Malnutrition Hypoproteinemia Scurvy •Pulmonary insufficiency COPDa Chronic cough •Immunosuppression Steroids Immunodeficiency states •Uremia •Jaundice/hepatic insufficiency •Diabetes mellitus a

Open

Laparoscopic

9 4

13 2

— —

— —

9 3

14 7

3 1 — — 5

6 — 1 — 9

Chronic obstructive pulmonary disease

Results

In the open group, the mean fascial defect was 148.4 ± 172.4 cm2 (range 28–600) compared to the laparoscopic group with a mean fascial defect of 105.1 ± 86.2 cm 2 (range 15.5–401) ( p 0.13). Five hernias were closed primarily in the open herniorrhaphy group and three in the laparoscopic group. The remaining 11 traditional open incisional hernia repairs required prosthetic material (10 Marlex, one GoreTex) and the remaining 18 laparoscopic repairs were completed with prosthetic material (Marlex). Operative time for the open repair ranged from 45 to 259 min with a mean of 97.6 ± 63.6 min. The laparoscopic group had an operative time ranging from 70 to 211 min with a mean of 128.5 ± 37.0 min. Though the time required for laparoscopic repair has diminished, the duration is highly dependent on the size and complexity of the hernia. Statistically there was no difference in operative time ( p 0.09). Four operations in the open group were performed on an outpatient basis and the remaining 12 patients had a 4.9 ± 5.6-day average length of hospitalization. Though there were no intraoperative complications, five of these patients had a prolonged length of stay which can be attributed to the morbidity of the operation. The postoperative complications included prolonged ileus (inability to tolerate liquids 72 h after operation, two), wound infection (one), bowel obstruction (one) requiring reexploration, and postoperative hypoxia (one). Two laparoscopic operations were performed on an outpatient basis and the remaining 19 patients had a 1.6 ± 0.9-day average length of hospitalization. There was one operative complication involving an enterotomy which required conversion to an open procedure in order to avoid the use of prosthetic material. This patient remained hospitalized for 4 days and has had no further complications at 5 months’ follow-up. Three patients in the laparoscopic group had a prolonged length of stay, which can be attributed to the morbidity of the operation. They included patients with pulmonary edema (one), persistent nausea and vomiting (one), and a small-bowel obstruction (one) which resolved with nonoperative management. One patient experienced transient shortness of breath immediately postoperatively but resolved spontaneously without prolonging the hospitalization. Only one patient in the laparoscopic group developed a postoperative seroma, which resolved without

Age Comorbidities Prior operation Prior repair Defect size

Traditional

Laparoscopic

60.4 ± 10.2 2.8 ± 1.9 3.6 ± 2.6 4 ± 3.6 148 ± 172 cm2

51.9 ± 13.5 3 ± 1.5 2.3 ± 1.4 2.1 ± 1.4 105 ± 86 cm 2

0.01 p p > 0.8 p > 0.09  p

0.13

a

Patients in the traditional group tended to be older but had a similar number of prior operations and comorbidities which would adversely affect hernia repair. Size was statistically different; the patients in the open group had larger fascial defects

intervention. Overall there was a 31% postoperative complication rate in the open group and 23% in the laparoscopic group. Complications in the open group required additional hospital stays averaging 11.4 days compared to those in laparoscopic group which averaged of 1.6 extra hospital days (Table 3). Open herniorrhaphies incurred total hospital costs of  $7,299 ± 5,312 ($2,056–21,744) with operative costs of  $1,435 ± 145 for the operating room and $528.2 ± 261 for surgical appliances. The laparoscopic cost averaged $4,395 ± 840 ($2,802–6,248) with operative costs of $1,572 ± 603 for the operating room and $905 ± 465 for surgical appliances. The one laparoscopic procedure converted to an open operation had a total cost of $6,506 with $1,664 operating room costs and $1,879 in surgical appliances. The operating room costs were not statistically different, p > 0.4, but total hospitalization costs were significantly different; the laparoscopic group was more cost effective ( p < 0.05). As is currently seen with other laparoscopic procedures, surgical appliance costs were significantly higher in the laparoscopic group ( p < 0.004) (Table 4). Follow-up was similar for both groups with a mean time of 18.8 ± 8.3 months (range 5–29) in the open herniorrhaphies and 20.0 ± 10.2 months (range 6–38) in the laparoscopic group, p 0.7. Telephone interviews of the open herniorrhaphy group revealed two patients who claimed to have recurrences (one which has been repaired). The other 14 patients have returned to daily activities and report no problems. Follow-up with the laparoscopic repairs revealed two patients who developed recurrences (both of whom underwent repeat laparoscopic repair at our institution). One patient developed a wound infection at a trocar site. Four patients complained of occasional pain for which they have not sought medical attention. Fifteen of the 19 patients have returned to daily activities and four remain on disability. Discussion

The ultimate role of the laparoscopic approach to ventral and incisional herniorrhaphy is unclear. There are many who believe that it is not warranted because of unknown effectiveness and costs. This study has taken a retrospective view of some of the parameters by which we need to critically assess the role of laparoscopy in the management of  patients with ventral and incisional fascial defects. Because this is a retrospective review there is an obvious selection bias. Small hernias (less than 25 cm 2) have little to gain from a laparoscopic repair. These can usually

34 Table 3. Operative and postoperative course a

Open Laparoscopic

Operative time (min)

Length of stay (days)

Morbidity

Recurrence

98 ± 64 128 ± 37

4.9 ± 5.6 1.6 ± 0.9

31% 23%

2 2

Wound infection Bowel obstruction •Requiring exploration Ileus Hypoxia Recurrence

Open

Laparoscopic

1 (required mesh removal) 1 1 2 1 2

1 (local treatment) 1

1 2

a

Comparison of open vs laparoscopic hernia repair groups. Though the average laparoscopic procedure was longer, the patients had a shorter hospital stay. Though the actual number of postoperative morbidities was similar, those in the open group tended to be more severe and led to a longer hospitalization

Table 4. Cost analysisa

OR costs Surgical supplies Total costs

Traditional

Laparoscopic

$1,435 ± 145 $528 ± 261 $7,299 ± 5,312

$1,572 ± 603 $905 ± 465 $4,395 ± 840

p > 0.4 0.003 p 0.05 p

a

Operative costs were similar except for the surgical appliances. Overall hospital costs were statistically different; the laparoscopic group was more cost effective due to shorter hospital stays and less-severe postoperative complications

be repaired primarily through small incisions and be sent home following an outpatient procedure. We also found that extremely large hernias can be difficult to approach laparoscopically due to the inability to place functional trocars. If  we are to attempt to have a minimum of 4 cm overlap of  mesh and healthy fascia, the trocars must be placed further away from the defect in the abdominal wall. With large hernias, this can sometimes result in placement of trocars too far laterally in the flanks, thereby making the operation either very difficult or impossible. For this reason there was a tendency to perform traditional open repair for the larger and more complex hernias. This obviously skews the data; However, some knowledge can still be gained from review. These results demonstrate some of the advantages and disadvantages of a laparoscopic approach in the repair of  incisional hernias. As with other laparoscopic procedures there appears to be a marked advantage to the patient in the immediate postoperative period. Though we did not directly measure postoperative pain, laparoscopic repairs in other abdominal procedures have demonstrated decreased pain as well as a lower incidence of gastrointestinal and pulmonary complications [6, 11, 14]. The earlier discharge of patients in the laparoscopic group reflects some of these advantages. Length of hospitalization alone had a significant bearing on the overall cost of the repair. Avoidance of painful abdominal wall incisions led to a quicker voluntary mobilization and to a decreased incidence of severe pulmonary complications; this shortened the postoperative hospital stay by an average of 3 days in the laparoscopic group. As previously mentioned, patients in whom the hernias can be repaired primarily were generally approached with an open technique. Many of the hernias which were ap-

proached laparoscopically for repair were incisional in nature. After lysis of adhesions, the majority of these defects are ultimately a ‘‘swiss-cheese’’ defect signifying undue tension on the abdominal wall, which we feel is best repaired in a tension-free fashion—i.e., with mesh or relaxing incisions. The three laparoscopic cases which were repaired primarily included two laparoscopic patients with an earlier recurrence due to insufficient stapling of one edge of the mesh. These patients simply had the free edge of the mesh reinforced with a hernia stapler. The other patient had a spigelian hernia which allowed adequate suture placement for a tension-free closure. Some have criticized the laparoscopic technique due to the intraperitoneal utilization of the prosthetic material as well as the choice of Marlex. The qualities of synthetic biomaterials have been well described by Scales [16] and Parviz et al. [13]: The proper synthetic mesh is not physically altered by tissue fluids, is chemically inert, does not produce foreign body reaction, is noncarcinogenic, is nonallergenic, is capable of resisting mechanical strains, and can be sterilized. Monofilament polypropylene meshes are the only biomaterials available today that fulfill all the above-mentioned requirements. Macroporous biomaterials with pore sizes larger than 10 ␮m, such as Marlex, allow infiltration of neutrophilic granulocytes which average 10– 15 ␮m. Biomaterials with pore sizes smaller than 10 ␮m can harbor infection of bacteria averaging 1 ␮m due to inadequate neutrophilic infiltration [12]. Also associated with the macroporous structure of Marlex mesh is a rapid fibrinous fixation by the host’s endogenous fibrin glue and therefore a lower incidence of seroma formation. Furthermore, the utilization of intraperitoneal Marlex mesh is not a forbidden practice. Several surgical atlases describe incisional herniorrhaphy techniques which involve intraperitoneal prosthetics [1, 3, 10, 13, 17, 19]: ‘‘Where possible, the omentum should be spread and interposed between the bowel and the mesh. A few rare cases have been reported of erosion and formation of a fistula in a loop of  bowel in contact with the mesh’’ [1]. Though popular in the repair of inguinal hernias, a preperitoneal approach to incisional hernias is virtually prohibitive. Attempts to separate the peritoneum of the hernia sac are met with serious obstacles at the site of scar formation. This frequently results

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