A E Chapman1, M D Levitt, P Hewett, R Woods, H Sheiner, G J Maddern. 1. Australian Safety & Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) project, Royal Australasian College of Surgeons, Adelaide, South Australia.
Abstract
OBJECTIVE: To compare the safety and efficacy of laparoscopic-assisted resection of colorectal malignancies with open colectomy. METHODS: Two search strategies were devised to retrieve literature from the Medline, Current Contents, Embase, and Cochrane Library databases until July 1999. Inclusion of papers was determined using a predetermined protocol, independent assessments by two reviewers, and a final consensus decision. English language papers were selected. Acceptable study designs included randomized controlled trials, controlled clinical trials, case series, or case reports. Fifty-two papers met the inclusion criteria. They were tabulated and critically appraised in terms of methodology and design, outcomes, and the possible influence of bias, confounding, and chance. RESULTS: Little high-level evidence was available. Laparoscopic resection of colorectal malignancy was more expensive and time-consuming, but little evidence suggests high rates of port site recurrence. The new procedure's advantages revolve around early recovery from surgery and reduced pain. CONCLUSIONS: The evidence base for laparoscopic-assisted resection of colorectal malignancies is inadequate to determine the procedure's safety and efficacy. Because of inadequate evidence detailing circumferential marginal clearance of tumors and the necessity of determining a precise incidence of cardiac and other major complications, along with wound and port site recurrence, it is recommended that a controlled clinical trial, ideally with random allocation to an intervention and control group, be conducted. Long-term survival rates need to be a primary aim of such a trial.
OBJECTIVE: To compare the safety and efficacy of laparoscopic-assisted resection of colorectal malignancies with open colectomy. METHODS: Two search strategies were devised to retrieve literature from the Medline, Current Contents, Embase, and Cochrane Library databases until July 1999. Inclusion of papers was determined using a predetermined protocol, independent assessments by two reviewers, and a final consensus decision. English language papers were selected. Acceptable study designs included randomized controlled trials, controlled clinical trials, case series, or case reports. Fifty-two papers met the inclusion criteria. They were tabulated and critically appraised in terms of methodology and design, outcomes, and the possible influence of bias, confounding, and chance. RESULTS: Little high-level evidence was available. Laparoscopic resection of colorectal malignancy was more expensive and time-consuming, but little evidence suggests high rates of port site recurrence. The new procedure's advantages revolve around early recovery from surgery and reduced pain. CONCLUSIONS: The evidence base for laparoscopic-assisted resection of colorectal malignancies is inadequate to determine the procedure's safety and efficacy. Because of inadequate evidence detailing circumferential marginal clearance of tumors and the necessity of determining a precise incidence of cardiac and other major complications, along with wound and port site recurrence, it is recommended that a controlled clinical trial, ideally with random allocation to an intervention and control group, be conducted. Long-term survival rates need to be a primary aim of such a trial.
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