Single Incision Laparoscopic Cholecystectomy Is Associated With a Higher Bile Duct Injury Rate: A Review and a Word of Caution.
Joseph M, Phillips MR, Farrell TM, Rupp CC.
Ann Surg. 2012 Jun 1. [Epub ahead of print]
Joseph et al. perform a systematic review of studies evaluating the safety of single incision laparoscopic cholecystectomy. Of 76 candidate studies, 45 met their inclusion criteria (n= 2,625 patients). A minority of patients (~9%) underwent cholecystectomy for acute cholecystitis. Across all studies there were 19 (0.72%) bile duct injuries. Based on comparison to historical rates of bile duct injury (~0.4% to 0.5%), the authors conclude that the single incision approach may be associated with a higher rate of bile duct injury. The authors go on to suggest controlled trials to more rigorously evaluate the safety of this new technique.
Question 1: Single incision laparoscopic surgery is a new innovation in surgery. What factors influence the uptake and diffusion of new surgical innovations? Based on these factors, is the single incision approach likely to be adopted as widely as standard laparoscopy?
Question 2: This systematic review combines several smaller case series, which are limited by publication bias, i.e., surgeons with the best outcomes are more likely to submit their results for publication. How would this bias impact this study? Is it valid to compare the results of this review to historical controls? What are the limitations of this approach?
Question 3: A randomized clinical trial would be the ideal method to evaluate the safety of this new approach to cholecystectomy. Given the low event rate for bile duct injury, approximately how many patients would be needed to adequately power such a study? Is such a trial feasible?
Please feel free to comment on any or all of the questions above. We look forward to hearing from you, the Annals readers.