Journal of Laparoendoscopic Surgery 1992.2:293-302. Downloaded from online.liebertpub.com by Uc Davis Libraries University of California Davis on 12/31/14. For personal use only.

JOURNAL OF LAPAROENDOSCOPIC SURGERY Volume 2, Number 6, 1992 Mary Ann Lieben, Inc., Publishers

Laparoscopic Cholecystectomy: An Initial Community Experience J. MICHAEL C. McGEE, M.D., F.A.C.S., MARK A. RANDEL, M.D., ROCKY M. MORGAN, M.D., MICHAEL G. NOLEN, M.D., GERALD E. WEAVER, M.D., KAREN F. MALNAR, R.N., C.T.R., WILLIAM S. YAMANASHI, Ph.D., and GLENN H. LYTLE, M.D.

ABSTRACT The initial 950 consecutive laparoscopic cholecystectomies performed in one city at four hospitals by 30 general surgeons are reported, covering a period from April 4,1990 to April 3, 1991. There were two operative deaths (0.2%), three common bile duct lacerations (0.3%), two subhepatic abscesses, two bowel perforations, and three bile leaks, two requiring laparotomy. Seven episodes of bleeding occurred, of which five required laparotomy, but none involved a major vessel. Sixty-five procedures were converted to open (6.7%). The mean operative time was 85.4 min. Intraoperative cholangiography was adequately completed in 49.8% and not attempted in 30.3%. Thirteen patients (2.7%) were found to have common duct stones. The pathologic diagnoses were chronic cholecystitis in 784 patients (82.5%), acute cholecystitis in 145 (15.3%), and cancer of the gallbladder in one (0.1 %). Hospital stays ranged from 4 h to 31 days (mean 49.5 h). This procedure can be learned and performed safely in a community setting.

INTRODUCTION March of 1987, Phillipe Mouret performed the first laparoscopic cholecystectomy.1"2 Dubois reported his initial series in January of 1990, which took place from May to December of 1988.3 Perissat reported 25 laparoscopic cholecystectomies in 19894 and 1990,5 from November 1988 to June 1989. In June of 1988, McKernan and Sayeft performed the first laparoscopic cholecystectomy in this country, followed in September by Reddick and Olsen.7 Since then, the procedure has enjoyed a rapid rise in popularity. This phenomenon has not been without controversy .48~14 Out of necessity, this procedure must be compared to open cholecystectomy15 in order to assess morbidity, mortality, short-term disability, and cost. These parameters have been reviewed.816^21 Laparoscopic cholecystectomy has become a common

In

University of Oklahoma College of Medicine, Department of Surgery, Research Section, Tulsa, OK. Abstract presented at Faculty Leadership Graduation, University of Oklahoma Health Sciences Center, Oklahoma City, OK on May 6, 1992, and Northeastern Oklahoma Society of Gastroenterology Nurses and Associates Regional Education Seminar, Embassy Suites, Tulsa, OK on May 30, 1992. 293

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FIG. 1.

Number of laparoscopic

cholecystectomies performed per surgeon.

procedure in the last 2 years. It is the purpose of this paper to review the performance and safety of 964 such procedures in one community at four different hospitals by 30 general surgeons over a 1 year period. METHODS

Beginning with the first laparoscopic cholecystectomy performed in Tulsa, OK, the authors included every consecutive procedure performed over the next year. All available charts were reviewed for preoperative diagnosis and assessment, operative time, morbidity, and mortality. In addition, it was ascertained whether each patient had preoperative antibiotics, a Foley catheter, a nasogastric tube, an intraoperative cholangiogram, and, if so, by what technique. The authors also looked at how many patients were converted to an open procedure, and if so why, and how much time elapsed prior to opening. Examination of whether drainage was required, if irrigation was used, and postoperative diagnoses also took place. All data were entered into StatSoft™ (Tulsa, OK) software and analyzed as reported in the following sections. In addition to hospital chart reviews, a questionnaire was sent to the 30 surgeons involved asking if and where they took a course and any complications or deaths that they noted. This study was retrospective and selection for this procedure was made solely by the attending surgeon. During this same period, 1,062 open cholecystectomies were performed at the same institutions and a review of final diagnoses and mortality was obtained from each hospital's medical record department. Patient selection for open cholecystectomy was also at the sole discretion of the attending surgeon. Table 1. Operative Mortality (n Cause

of Death

Respiratory failure Biliary sepsis Total Other Deaths Melanoma

Lung

cancer

Renal failure Total

Postop Days 24

31

=

950) No. I I

2 33

59-355 370

(0.2%)

I 4 1

6

294

of Deaths

(0.6%)

Table 2. Morbidity

950 Cases

Percentage of

Complication

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of

No. Cases

Total Cases

Bleeding

2 3 8

.32 .21 .21 .32 .84

Missed dx (colon carcinoma,

2

.21

3 I 3 27

.32 .10 .32 2.85

Common bile duct lacerations Subhepatic abscess Bowel perforation Bile leak

3 2

appendicitis) Wound infection Incisional hernia Normal path reports Total Morbidity

RESULTS Between April 4, 1990 and April 3, 1991, 964 laparoscopic cholecystectomies were performed and charts were reviewed. These procedures were performed by 30 different general surgeons in private practice at four different hospitals. All surgeons involved took a 2-to-3 day course in at least seven different course locations. Some observed the procedure as performed by other surgeons and/or participated in procedures performed by other surgeons in other cities. One surgeon performed 212 laparoscopic cholecystectomies and only three other surgeons performed 50 or more laparoscopic cholecystectomies. The mean number of procedures per surgeon was 25.27, deleting the surgeon with 212 cases (Fig. 1). Out of 964 procedures, 14 charts were not available for review, although discharge primary and secondary diagnoses were obtained and included mortality and morbidity calculations. All deaths and major morbidity were also obtained. The following results represent 950 cases, 98.5% of the total excluding the categories of mortality and major morbidity where their is 100% representation. There were two deaths within 1 month of laparoscopic cholecystectomy, creating an operative mortality of 0.2%. One was due to primary pulmonary disease. The second patient had choledocholithiasis and was

°

Mean

I IStd.Err.

T

Group 1

Group Z

FIG. 2.

=

îStd.Dev.

= Opened N=62 Not Opened N=875

Hospital stay comparison of open vs. 295

not

opened laparoscopic cholecystectomies.

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FIG. 3.

Age distribution.

converted from laparoscopic to open cholecystectomy with a common bile duct exploration, and ultimately died of persistent biliary sepsis. There were six other deaths within approximately 1 year of follow up, but all were unrelated to cholecystitis. Five of the six died of different types of carcinoma and one died 370 days after her cholecystectomy, of renal fai lure (Table 1 ). Of the concurrent 1,062 open cholecystectomies, there were 13 deaths. In the laparoscopic cholecystectomy series, there were three common bile duct transections, all with immediate repair. All of these occurred in the operator's first few procedures. There were two subhepatic abscesses requiring drainage and two bowel perforations necessitating repair. There were three bile leaks, two of which required laparotomy. There were five episodes of bleeding requiring conversion to open procedure, but none involved a major vessel. There were three minor episodes of bleeding, none requiring laparotomy. There were two missed diagnoses: one colon cancer and one acute appendicitis. There were three wound

Height in Pounds

FIG. 4.

Weight distribution. 296

Table 3. Diagnostic Tests

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Tests Run US CT ERCP OCG Undocumented Total

Total No. Tests

Percentage

Number of Positive Tests

% of Positive Individ. Tests

741

81.2 3.3

759

51

96.0 81.3 73.3 76.1

847

86.96

of Total

32 07

15

1.5 6.9

69

7.1

974

26 II

infections treated with incision and drainage. There was one incisional hernia. There were three normal pathology reports for a morbidity rate of 2.85% (Table 2). Sixty-five procedures were converted to open cholecystectomies (6.7%). Reasons for opening included: operative difficulty (33), common duct stones (9), adhesions (4), bleeding (5), purulence (3), and unknown (10). The mean time for conversion to an open procedure was43.8min, witharange of 3 to 110min(N 26 of 65 cases). Forty percent of these converted patients had a pathologic diagnosis of acute cholecystitis, compared to the total laparoscopic group acute cholecystectomy rate of 15% (p < .0001 ). The mean age of the 65 patients that were opened was 55.3 years which was older than the group not opened, mean 49.8 years (p .009). The operative time was prolonged in the opened group from a mean of 85.4 to 101.77 min (p < .000). The postoperative hospital stay of the opened group was increased over the laparoscopic cholecystectomy group from 42.14 to 154.3 h (p < .000, Fig. 2). Of the total patients, 733 were female (77%). The ages of all patients ranged from 4 to 93 years old with a mean of 49.9 years and a standard deviation of 16.8 years (Fig. 3). The mean weight was 169.2 lbs, with a range of 44 to 385 lbs. The number of patients weighing greater than 200 lbs. was 174 (18.3%), and only 13 patients weighed less than 99 lbs. (Fig. 4). Four hundred fifty-nine patients had previous abdominal surgery in the lower abdomen. Fifteen had previous upper abdominal surgeries and fourteen more had previous upper and lower abdominal surgery =

=

(2.9%).

The preoperative diagnosis was made by ultrasound in 759 patients, oral cholecystogram in 51, computer tomography in 26, ERCP in 11, and undocumented in 69 (Table 3). The preoperative diagnosis was

FIG. 5.

Operative time. 297

200

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150

mean



op time I.

Apr May FIG. 6.

Aug.

Jun Jul

Oct

Sep

Dec Jan

Nov

procedures

J

Feb

Comparison by month of mean operative time vs.

Mar

number of procedures.

symptomatic gallstones or chronic cholecystitis with stones in 811 patients (85.4%), acute cholecystitis in 117 (12.3%), and other or not documented in 22 (2.3%). The

operative time was 85.4 min with a range of 25 to 375 min (Fig. 5). Eighty-five percent of the less than 120 min. Operative time decreased over the study period (Fig. 6) as the number of procedures performed by the group increased. There was also prolonged operative time in those with a diagnosis of acute cholecystitis, from a mean of 85.4 min to 102.1 min (p < .001, Fig. 7). Preoperative antibiotics were given in 803 patients (84.5%). They were not given in 93 (9.8%) and undocumented in 54 (5.7%). There were 19 different choices of antibiotics, but in 748 cases it was a first or second generation cephalosporin. Intraoperative irrigation was documented in 92.6%, which included antibiotics in 57.2% and heparin in 81.5%. Electrocautery was used in 812 patients (85.5%) and laser use was mean

cases were

=

°

Mean

I ±Std.Err.

T 2 group

Group 1 Group 2

FIG. 7.

= =

Acute N Chronic N

= =

140 762

Comparison of operative time, acute vs. 298

chronic.

IStd.Oev.

Table 4. Cholangiography (n

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No.

=

950)

Cholangiograms

Attempted and adequate (via gallbladder) Attempted but inadequate Attempted and failed Not attempted Unknown

of Cases

473

49.8

(84)

(17.7)

29 150 288 10

3.1 15.8 30.3 1.0

documented in 25 patients (2.6%). In 14% of the cases, there was no documentation of laser or cautery. A Foley catheter was placed in 739 patients (77.79%) and a nasogastric tube in 855 patients (90.0%). An intraoperative cholangiogram was attempted in 652 patients (68.6%). It was deemed adequate in 473 (49.8%), completed but inadequate in 29 (3.1%), and attempted but failed in 150 (15.8%). Cholangiography was not attempted in 288 cases (30.3%) (Table 4). Thirteen patients (2.7%) on cholangiograph were felt to have common duct stones. Ten were opened and explored and one was opened but did not have common bile duct exploration; two of these patients were followed expectantly. There was no significant prolongation of mean operative time in those patients undergoing cholangiography (p .038). Cholangiography done via the time 13 min reduced those whose over gallbladder operative by cholangiography was performed via the cystic duct (Fig. 8). Stones were left free in the abdomen in 17 patients (1.8%) with no reported adverse sequelae. The gallbladder was removed via the umbilical port in 761 (80.1 %), via the superior midline port in 90 (9.5%), and not documented in 35 (3.7%). There were 21 concurrent procedures done, including 10 liver biopsies, 8 cases of adhesiolysis, 2 umbilical herniorrhaphies, and 1 ovarian cyst aspiration. There were 92 drains placed, 72 closed suction, 12 t-tubes, and 8 drains of undocumented type. The pathologic diagnosis was chronic cholecystitis with cholelithiasis in 784 cases (82.5%); acute cholecystitis in 145 (15.3%); other in 5 (.5%), including 3 normal gallbladders, 1 cancer of the gallbladder; and 16 (1.8%) undocumented (Table 5). Postoperative hospital stays ranged from 4 h to 31 days. Three patients' hospital stays were 30 to 31 days with a mean of 49.6 h. Excluding these three patients, the mean hospital stay was 47.3 h (Fig. 9). The number =

Mean

SStd.Err. îStd.Oev.

Group 1

Group 2

FIG. 8.

via GaI IbI adder v i a Cyst i c Duct

N N

83 379

Cholangiography via gallbladder and cholangiography via cystic duct vs. operative time. 299

Table 5. Pathology Diagnosis (n

=

950)

Number of Cases

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Diagnosis

Diagnosed

Chronic cholecystitis with stones Acute cholecystitis Other Undocumented

Percentage Total No. of Cases

5

82.5 15.3 .5

16

1.7

784 145

of patients out of the hospital in 72 h was 86.3%, and the mean for this subgroup was 29.8 h. The diagnosis of acute cholecystitis prolonged the mean hospital stay from 46.5 to 67.79 h (p .001, Fig. 10). =

DISCUSSION

Any new procedure must be compared in terms of efficacy and safety with previous standard therapies. McSherry reported a mortality rate for open cholecystectomy of 0.2%.I5 The concurrent nonrandomized series of open cholecystectomies (1,062) performed in the same institutions had 13 deaths (1.22%), and certainly represents a more complicated group of patients. The operative mortality rate in this laparoscopic cholecystectomy series of 0.2% is acceptable. While learning this new procedure, admittedly more straightforward patients were selected for laparoscopic cholecystectomy while the open procedure was relied on for more difficult patients. The reported rate of common bile duct injuries in the open procedure ranges from 0.3-0.5%.22~25 Three common bile duct injuries (0.3%) fall within accepted published rates for open procedures.2225 All of these injuries occurred early in the operator's experience, confirming some observations that the early rate of common duct injury may be higher than what should be expected later. This report includes 30 learning curves, i.e. the first few procedures of all the involved surgeons and their overall rates of mortality and morbidity are not excessive. The operative time decreased significantly over the course of the study, settling at about 75 min and remaining essentially unchanged for the latter 6 months of the period.

-200

-100

FIG. 9.

Postoperative hospital stay. 300

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I

T

Acute Path Diagnosis Chronic Path Diagnosis

FIG. 10.

N

=

143

N

=

733

I iStd.Err. iStd.Dev.

Comparison of postoperative hospital stay, acute vs. chronic.

Cholangiography was successfully completed in only 50% of the patients and in 30% it was not even attempted. At least two of three common duct injuries occurred without cholangiography. It has become the consensus in this community that intraoperative cholangiography should be attempted routinely. It is interesting that in this study it does not significantly prolong operative time, and in fact may shorten it if performed via the gallbladder early on in the operation. The hospital stay was longer than other laparoscopic cholecystectomy series,6'6-'8 but 15% of this series had an acute diagnosis, and this significantly prolonged hospital stay. The 6.7% conversion to open rate is higher than other series,1618-26-27 but probably reflects a high rate of acute pathology, the learning curve of 30 surgeons, and a justifiable early timidity. CONCLUSIONS The authors conclude that 30 general surgeons attending a variety of training courses can safely perform 964 laparoscopic cholecystectomies at four different hospitals.

ACKNOWLEDGMENT The authors would like to acknowledge and thank Charlette Bellefeuille, CTR, for her work in gathering and inputting data into StatSoft™ and generating statistical data, and Audrey Spring for preparation of the

manuscript.

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Address reprint requests to: J. Michael C. McGee, M.D., F.A.C.S. Department of Surgery, Research Section 2815 South Sheridan Road Tulsa, Oklahoma 74129-1045

302

Laparoscopic cholecystectomy: an initial community experience.

The initial 950 consecutive laparoscopic cholecystectomies performed in one city at four hospitals by 30 general surgeons are reported, covering a per...
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