The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. METHODS: A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images. RESULTS: DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients. CONCLUSION: DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

Surgeon experience and trends in intraoperative complications in laparoscopic cholecystectomy.

BACKGROUND: Intraoperative complications, particularly bile duct injuries (BDIs), have increased since the introduction of laparoscopic cholecystectomy (LC). This excess risk is expected to decline as surgeon experience in laparoscopic surgery increases. METHODS: This was a population-based study of trends in intraoperative injuries in 33 309 cholecystectomies carried out in Western Australia between 1988 and 1998, based on hospital discharge abstracts. Endpoints were identified from diagnostic and procedure codes in index or postoperative readmissions, or a register of endoscopic retrograde cholangiopancreatography procedures, and validated using hospital records. Multivariate analysis was used to estimate the risk of complications associated with potential risk factors. RESULTS: Following the introduction of LC in 1991, the prevalence of all complications doubled by 1994 then stabilized, whereas that of BDI declined after 1994. The risk of complications increased with age, was higher in men, teaching and country hospitals, and was higher for LC and more complicated operations. It was lower when intraoperative cholangiography was performed and with increasing surgeon experience. Approximately 20 per cent of all complications and 30 per cent of BDIs were attributable to surgeons who had performed 200 or fewer cholecystectomies in the previous 5 years. CONCLUSION: The risk of intraoperative complications declined with increasing surgical experience and use of intraoperative cholangiography.

Preoperative assessment of pancreatic malignancy using endoscopic ultrasound.

BACKGROUND: Endoscopic ultrasound (EUS) has been regarded as the most accurate modality for locoregional staging of pancreatic malignancy. However, several recent studies have questioned this. The current study assessed the accuracy of EUS in determining preoperative resectability of pancreatic neoplasia. METHODS: A retrospective review was performed of patients with pancreatic malignancy who had preoperative EUS and underwent surgery. EUS-predicted resectability was compared with surgical resectability. Where available, accuracies of vascular and nodal staging were also assessed. RESULTS: Forty-five patients were identified (mean age 60 years, age range = 36-79 years). All patients underwent surgical exploration; vascular staging was available in 32 cases and 17 cases underwent surgical resection. The sensitivity, specificity, and accuracy of EUS in determining unresectability were 66%, 100%, and 78% respectively. Overall EUS stage concurred with surgical stage in 56%, greater than surgical stage in 4%, and less than surgical stage in 40%. Vascular staging on EUS had a sensitivity of 69% and a specificity of 100%. Accuracy of nodal staging was 71%. CONCLUSION: EUS had a high specificity for assessing unresectable pancreatic malignancy. This technique should be used to avoid unnecessary surgical exploration of incurable lesions. However, EUS had only a moderate sensitivity, and a proportion of patients staged preoperatively as having resectable disease will not be surgically resectable.

Gallstones. Modern management.

BACKGROUND: Management of gallstones has changed as a result of new technologies, such as ultrasound, endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic surgery. OBJECTIVE: This paper describes the clinical situations in which gallstones occur and their natural history. This is then related to the advantages and disadvantages of ERCP, laparoscopic cholecystectomy and open cholecystectomy. DISCUSSION: Laparoscopic cholecystectomy has become the treatment of choice, but does have risk of serious complications of which the patient should be informed. Incidental gallstones should generally be left untreated. Patients presenting with biliary pain are certain to develop recurrence and require elective cholecystectomy. Those with acute cholecystitis should be managed early, with laparoscopic or open operation depending on the experience of the surgeon. Patients with obstructive jaundice can undergo laparoscopic duct exploration or have an ERCP/sphincterotomy. Those with gallstone pancreatitis should have laparoscopic cholecystectomy within the same hospital admission.

Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a population-based study.

BACKGROUND: Previous studies suggest that laparoscopic cholecystectomy (LC) is associated with an increased risk of intraoperative injury involving the bile ducts, bowel, and vascular structures compared with open cholecystectomy (OC). Population-based studies are required to estimate the magnitude of the increased risk, to determine whether this is changing over time, and to identify ways by which this might be reduced. METHODS: Suspected cases of intraoperative injury associated with cholecystectomy in Western Australia in the period 1988 to 1994 were identified from routinely collected hospital statistical records and lists of persons undergoing postoperative endoscopic retrograde cholangiopancreatography. The case records of suspect cases were reviewed to confirm the nature and site of injury. Ordinal logistic regression was used to estimate the risk of injury associated with LC compared with OC after adjusting for confounding factors. RESULTS: After the introduction of LC in 1991, the proportion of all cholecystectomy cases with intraoperative injury increased from 0.67% in 1988-90 to 1.33% in 1993-94. Similar relative increases were observed in bile duct injuries, major bile leaks, and other injuries to bowel or vascular structures. Increases in intraoperative injury were observed in both LC and OC. After adjustment for age, gender, hospital type, severity of disease, intraoperative cholangiography, and calendar period, the odds ratio for intraoperative injury in LC compared with OC was 1.79. Operative cholangiography significantly reduced the risk of injury. CONCLUSION: Operative cholangiography has a protective effect for complications of cholecystectomy. Compared with OC, LC carries a nearly twofold higher risk of major bile, vascular, and bowel complications. Further study is required to determine the extent to which potentially preventable factors contribute to this risk.

Distal colonic neoplasms predict proximal neoplasia in average-risk, asymptomatic subjects.

Flexible sigmoidoscopy has been recommended as a screening method to reduce the incidence of colorectal cancer in asymptomatic, average-risk subjects through the early detection and removal of polyps. However, the association between distal and proximal colonic neoplasia and, hence, the requirement for colonoscopic follow up of screen-detected distal neoplasms is unclear. Our aims were: (i) to evaluate the risk of having proximal neoplasms in those with distal colonic neoplasms; and (ii) to determine whether the risk was dependent on the number, size, histology or morphology of the distal lesions. We prospectively evaluated asymptomatic subjects in a flexible sigmoidoscopy based screening programme. Those with rectosigmoid neoplasia underwent colonoscopy. The number, size, histology and morphology of the polyps were recorded. Advanced lesions were defined as adenomas > 1 cm or with a villous component or severe dysplasia, carcinoma in situ or cancer. Adenomatous polyps were found in 17% (135) of screening flexible sigmoidoscopies. At colonoscopy, up to 30% of subjects with distal colonic neoplasms had synchronous proximal lesions at colonoscopy and up to 20% had advanced proximal lesions. The risk of proximal colonic neoplasia was increased in those with distal sessile colonic neoplasms but appeared independent of distal lesion size, number or morphology. In conclusion, distal colonic neoplasia predicts proximal neoplasia in up to 30% of subjects and these were advanced lesions in up to 20%. We recommend that all subjects with biopsy proven distal colonic neoplasia undergo colonoscopy.

One hundred liver resections including comparison to non-resected liver-mobilized patients.

BACKGROUND: Factors of liver resection associated with postoperative recovery and survival, the modalities that affect survival with resected colorectal carcinoma liver metastases, the comparison of liver function of liver-resected to liver-mobilized but not resected patients, and observation of early liver regeneration volume over time have not been studied prospectively. This study aimed to prospectively analyse these factors. METHODS: Data were collected prospectively on 100 consecutive liver resections, and 10 liver-mobilized but not resected patients by the Hepatobiliary Unit, University of Melbourne, Austin Campus. Follow-up of patients was 100%. RESULTS: The factors associated with blood loss were the type of liver resection (P = 0.0001), the length of the operation (P = 0.0001) and a central venous pressure greater than 5 cm of water (P = 0.0008). An inverse correlation existed between blood loss and long-term survival (P = 0.003). The only predictor for a postoperative complication was the length of the operation (P = 0.03): a correlation of moderate significance existed between blood loss and a complication (P = 0.052; confidence interval 0.19-1.17). The 5-year cumulative survival for hepatic resection for colorectal carcinoma Dukes A + B was 55%; there was a significantly better survival of Dukes A + B compared to Dukes C (P = 0.03) and also for those 50 years or older, but this did not depend on whether there were one or more lesions present. Resected patients had a significantly higher alanine transaminase (ALT), total bilirubin and international normalized ratio than non-resected patients, but not albumin, total protein, alkaline phosphatase or aspartate aminotransferase. The serum albumin fall was similar in both groups, which indicated that loss of liver tissue was not the cause. The re-resection rate was 8% without mortality and with low morbidity. Liver volume was restored by 64% (510 +/- 170 cc) by 7 days postoperatively. CONCLUSIONS: Major hepatic resection can be performed with low mortality, morbidity and short hospital stay, with a 5-year survival for colorectal carcinoma better than 50%. Resection needs to be considered more frequently for curative management. Serum albumin fall is not caused by loss of liver tissue and blood loss can be controlled by central venous pressure manipulation and vascular isolation. Re-resection is a safe and rewarding treatment and needs to be planned at the first resection.

The Quality of Surgical Care Project: a model to evaluate surgical outcomes in Western Australia using population-based record linkage.

BACKGROUND: The aim of this study is to establish a model to evaluate surgical outcomes and, where indicated, recommend changes to improve the quality of surgical care in Western Australia (WA). Open resection for aneurysm of the abdominal aorta was the first procedure evaluated and the results are reported in an accompanying paper. METHODS: The Quality of Surgical Care Project (QSCP) is conducted under the aegis of the Royal Australasian College of Surgeons (RACS) in WA, and brings together a multidisciplinary team of surgeons, public health researchers and health service administrators. The Western Australia Health Services Research Linked Database (the WA Linked Database) is used to provide linked chains of patients records residing in the state health department from the following sources: hospital morbidity data system, birth and death records, mental health services data, cancer registrations and midwives' notifications. This links 16 years of population-based patient records from 1980, including all public and private hospital admissions and re-admissions. The Quality of Surgical Care Project was established to use and to correlate the data from the WA Linked Database. RESULTS: The result is a powerful database for a contained population that is available for scientific analysis by a multidisciplinary team of clinical epidemiologists, surgeons and health service managers. Users will have the ability to establish benchmark standards for the outcomes of surgical procedures in WA for use in quality improvement programmes run by the College and will facilitate self-directed performance auditing activities as a commitment to greater community accountability. CONCLUSIONS: The Quality of Surgical Care Project provides a potential model of benefits to be realized by both the medical profession and the community through multidisciplinary collaboration supported by adequate information. Although migration from WA is relatively low, future linkage to the state electoral roll will allow correction for any population change.

Colorectal cancer screening by general practitioners: comparison with national guidelines.

OBJECTIVE: To determine whether general practitioners (GPs) had received Australian guidelines on early detection, screening and surveillance for colorectal cancer or rectal bleeding, and whether their reported practice conformed with these guidelines. DESIGN: Cross-sectional postal survey of self-reported practice. PARTICIPANTS AND SETTING: 213 GPs in practice in the southern metropolitan area of Perth, Western Australia, were randomly selected from the Fremantle Regional Division of General Practice database and surveyed in March 1997. RESULTS: Replies were received from 155 (73%) of the GPs, and 110 reported receiving guidelines (from the Australian Gastroenterology Institute [AGI], 44; Gut Foundation of Australia [GFA], 40; others, 6; and not specified, 20). GPs who reported receiving guidelines were significantly more likely to screen for colorectal cancer (99/110; 90%) than those who reported not receiving guidelines (33/45; 73%) (P = 0.008). The commonest method to investigate people with identifiable risk factors for colorectal cancer was colonoscopy. Reported screening frequencies in asymptomatic patients with above-average risk (family history of colorectal cancer or past history of adenomatous polyps or colorectal cancer) were significantly higher than recommended by AGI and GFA guidelines (P < 0.05). Up to 24% of GPs investigated altered bowel habit or bleeding per rectum with faecal occult blood testing. CONCLUSIONS: Most GPs report having received guidelines. Reported screening frequency was higher than recommended for most above-average-risk patients, which will result in excessive consumption of resources without benefits for cancer prevention.

Peptic disease: can we afford current management?

BACKGROUND: While surgery has the potential to cure peptic disease (ulceration and reflux), the development in the 1970s of H2 receptor antagonists saw them replace surgery in the management of peptic symptoms, controlling disease while the medication was taken. Medical cure at least in the case of a duodenal ulcer is now also possible by the use of anti-Helicobacter therapy. METHODS: Australian Pharmaceutical Benefits Scheme (PBS) and Medicare data on the treatment of peptic disease were reviewed. RESULTS: The data showed that medical cure of duodenal ulcer is rarely attempted. While elective surgical treatment for duodenal ulcer, highly selective vagotomy, has decreased 10-fold in 10 years, prescriptions for antisecretory agents (H2 and proton pump) are doubling every 2 years (increasing from 6.7 to 7.8% of PBS budget). Meanwhile upper gastrointestinal endoscopy rates are doubling every 5 years. By comparison, the most appropriate treatment, anti-Helicobacter therapy, is prescribed at 1/50th the rate of antisecretory agents and over 2 years decreased to 1/80th. Antisecretory treatment has not been effective in reducing mortality from duodenal ulcer, at least not in New South Wales. CONCLUSIONS: If the principle of treatment is to decrease cost and prevent complications by curing duodenal ulcer, then current practice is a failure. A management algorithm for peptic symptoms which has the potential to relieve symptoms, cure ulcer when present, minimize surgery and reduce complications and cost is proposed for the purpose of debate.

Flexible sigmoidoscopy screening for colorectal cancer in average-risk subjects: a community-based pilot project.

OBJECTIVE: To test a pilot screening program for colorectal cancer. DESIGN: Subjects, chosen at random and recruited by mail, were examined by flexible sigmoidoscopy. PARTICIPANTS AND SETTING: Normal-risk, asymptomatic men and women aged 55-59 years recruited from the community, July to December, 1995. MAIN OUTCOME MEASURES: Number of polyps detected and cancers diagnosed, and compliance with screening. RESULTS: Letters of invitation were sent to 3500 subjects; of these, 2881 were eligible for inclusion in the study and 342 (12%) consented to participate. A further 3.5% of non-compliant subjects attended the screening program after a telephone survey assessing reasons for non-attendance. Common reasons for non-attendance were a lack of interest (30%) or a lack of time, mainly due to work commitments (28%). A third of subjects had polyps and 46% of these were adenomas. Three subjects were found to have adenocarcinoma: in two the cancer was confined to a polyp and treated with polypectomy, and one subject underwent anterior resection (overall prevalence of cancer, 0.9%). The median depth of insertion achieved with flexible sigmoidoscopy was 55 cm (range, 25-100 cm). Median pain level (on a scale of 0 = no pain to 10 = worst pain imaginable) was 2 (range, 0-8.5), and 99% of the subjects would have the test again if required. CONCLUSIONS: Flexible sigmoidoscopy was well tolerated and had an acceptable detection rate of adenomatous polyps and early cancer. Subject compliance emerged as a major issue which requires further evaluation to maximise participation in future programs.

Laparoscopic cholecystectomy: what national benefits have been achieved and at what cost?

Changes in the practice of surgery following the introduction of laparoscopic cholecystectomy (removing asymptomatic gallstones, duplicating procedures for diagnosing and managing common bile duct stones, and deferring laparoscopic management of complicated gallstones) as well as the increased rate of complications (particularly duct injury), have eroded the economic benefits to health care funders of shorter hospital stays. However, these benefits may be achieved if laparoscopic procedures are performed only by experienced surgeons and if the procedure is offered to all patients with gallstones, including complicated cases. Benefits to the community remain in terms of productivity savings as a result of an earlier return to work for patients.

Biliary tract complications of laparoscopic cholecystectomy are detected more frequently with routine intraoperative cholangiography.

Controversy over whether intraoperative cholangiography (IOC) should be done routinely has intensified since the advent of laparoscopic cholecystectomy (LC). As yet, no study has demonstrated a clear benefit to its use, although their have been suggestions in the literature that routine use may confer an advantage to detection of injuries. One-hundred seventy-seven biliary tract complications occurring secondary to LC were identified from the combined data of seven institutions. The goal of this retrospective study was to examine the impact of IOC on the occurrence, recognition, and correction of such complications. The complications identified include 39 cystic duct leaks, 69 major ductal leaks or strictures, and 69 major ductal transection or excision injuries. Whether IOC was performed was known in 157 (88%) patients with 53 patients definitely having and 104 not having an IOC. Data concerning IOC were unavailable in 20 cases. More injuries were detected intraoperatively in the group having IOC (P < 0.001). Conversion of the LC to a laparotomy, often for repair of the injury, occurred more commonly in the group having a correctly interpreted IOC (P < 0.001). Conversion resulted in detection of injuries sooner, resulting in fewer operative procedures to correct the injury (P < 0.001). A transecting injury was prevented in at least seven patients when no visualization of the proximal biliary tree was documented by IOC. These partial ductal incisions were treated by t-tube placement. Incorrect interpretation of the IOC occurred in at least eight patients, with no identification of the proximal biliary tree in six.(ABSTRACT TRUNCATED AT 250 WORDS)

The carcinogenic risks of alcoholic beverages: implications for cancer education.

The proper analysis of the data generated by studies of carcinogenic risks of drinking alcoholic beverages would be the application of models from the relatively new approach of meta-analysis. In this study, 441 articles were generated by a 1992 MEDLINE search of the key words "alcohol drinking" and "cancer." Of these, only 29 met the criteria for a formal meta-analysis. For these 29 research reports, the 95% confidence limits for the odds ratio were 1.28 and 1.15, suggesting a weak association between drinking and cancer. This conclusion was rendered even less decisive by the following problems in the studies analyzed: 1) absence of comparable measures of either dosages or drinking patterns; 2) absence of comparable methods of data analysis; 3) absence of comparable measures of other population characteristics; and 4) widely varying results from study to study. For example, the 95% confidence limits for the odds radio of the 16 European studies were 1.14 and 0.98, indicating not even a reliable directional difference between drinking and nondrinking populations. Although the World Health Organization International Agency for Research on Cancer concluded in 1987 that alcoholic beverages are carcinogenic, the scientific literature extant in 1992 provides only very weak support for that finding. There is a need for multiple nonexperimental investigations using methods that will produce results sufficiently comparable to justify the application of the statistical models being generated for the meta-analysis of important questions not subject to direct experimentation.(ABSTRACT TRUNCATED AT 250 WORDS)

Laparoscopic adrenalectomy.

Minimal access surgery continues to expand its applications now including laparoscopic adrenalectomy. Two differing intraperitoneal techniques are described in six patients, three with Conn's Syndrome, one with a Cushing's tumour, one with a phaeochromocytoma and one with a large non-functioning cortical adenoma. This initial Australasian experience with the procedure followed careful preparation in the cadaver and pig.

The role of the kidney in the clearance of calcitonin gene related peptide (CGRP).

Calcitonin gene-related peptide (CGRP) is a 37 amino-acid peptide, undetectable in the plasma in health but elevated in certain disease states such as medullary thyroid cancer, and potentially causes symptoms. The kidney is a major site of and influence on the clearance of exogenously infused CGRP. As CGRP might cause symptoms in renal dysfunction, this study was performed to determine the clearance of CGRP in humans and animals with altered renal function. In chronic renal failure patients, CGRP was not detected in plasma either before or after haemodialysis. In sheep, before and after bilateral nephrectomy, there was an approximate halving of plasma clearance and doubling of the circulating half-life of infused CGRP. This reduction in clearance was greater than that which could be accounted for by the reduction in degradation by renal substance alone. This renal influence on extra-renal CGRP metabolism was not due to the renal production of a circulating peptidase as evidenced by the absence of such peptidase in the plasma of normal and anephric sheep. Further, severity of uraemia had no influence on the extra-renal metabolism. The mechanism by which the kidney influences the extra-renal metabolism of CGRP remains obscure.

Changes in the practice of biliary surgery and ERCP during the introduction of laparoscopic cholecystectomy to Australia: their possible significance.

Two and a half years after the introduction of laparoscopic cholecystectomy to Australia in February 1990, estimates from Medicare statistics suggest that by July 1992, 69% of cholecystectomies were being performed laparoscopically. There was a smaller decline in the numbers of open cholecystectomies performed, suggesting a 28% rise in the rate of cholecystectomy. This has been associated with a 66% decline in the use of intra-operative cholangiography. Whereas 87% of cholecystectomies had an operative cholangiogram performed, now only 23% of all cholecystectomies do. It is suggested that in approximately half the patients, no attempt is made to exclude common duct stones. With those patients in whom an attempt is made, most surgeons rely on endoscopic retrograde cholangiopancreatography, as evidenced by a 43% increase in its use, or, more recently, a small proportion of surgeons have been using intravenous cholangiography, as evidenced by a 26% increase in its use. Once diagnosed, these stones are no longer being treated by open exploration of the bile duct, indicated by a 46% decrease in this procedure, but are being treated by endoscopic sphincterotomy, which has shown a 242% increase in its use. From the published results of the outcome of these treatments, the added risk, nationally, of these additional procedures in managing uncomplicated bile duct stones is predicted to increase mortality 1-3-fold and morbidity 10-15-fold. This risk can be reduced by the use of laparoscopic bile duct exploration. These techniques are already well established and can be learnt quickly if practice is achieved by performing routine intra-operative cholangiography.(ABSTRACT TRUNCATED AT 250 WORDS)

An evaluation of laparoscopic versus open cholecystectomy.

OBJECTIVE: To compare open cholecystectomy (OC) with laparoscopic cholecystectomy (LC) in terms of clinical aspects and a limited review of costs. SETTING: The Austin Hospital, Melbourne, a university teaching hospital. DESIGN: Prospective LC patients were compared with a retrospective group of OC patients whose surgery had been performed by the same surgeons. METHODS: Consecutive patients undergoing LC were interviewed, their medical records were analysed and the cost of their hospitalisation was assessed. Similar data, collected previously from patients undergoing OC, were used for comparison. RESULTS: There were 108 patients in each group, 93.5% treated electively. All had gallstones. No deaths or common bile duct injury occurred. The mean operating room time was 131 +/- 3.7 minutes for OC and 164 +/- 4.7 minutes for LC. Operative cholangiography was attempted in 80% in each group, being successful when attempted in all OCs and in 95% of LCs. The conversion rate of LCs to OCs was 4.5%. Minor complications were more frequent with OCs. The mean duration of hospital stay was 6.5 +/- 0.3 days for OCs and 2.0 +/- 0.2 days for LCs. The amount and period of analgesia were significantly less in the LC group. Patients recovered significantly faster after LC (P < 0.01) during the first eight weeks after surgery. There was no difference by 12 weeks. The overall cost for each LC was $838 less than OC for the entire hospital stay. CONCLUSION: These results support the view that LC is a safe and justified replacement for OC in the elective situation, with benefits to the patient, hospital and general community. The hospital cost for LC was less than for OC.