Randomized clinical trial of small-incision and laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis

Objective: To evaluate the primary and clinical outcomes in laparoscopic and small-incision cholecystectomy. Design: Blinded randomized single-center trial emphasizing methodologic quality and generalizability. Setting: General teaching hospital in the Netherlands Patients: A total of 257 patients undergoing cholecystectomy for symptomatic cholecystolithiasis. Interventions: Laparoscopic cholecystectomy and small-incision cholecystectomy, performed mainly by surgical residents. Main Outcome Measures: Complications and symptom relief were primary outcome measures; conversion rate, operative time, and hospital stay were secondary out-come measures. Feasibility of performing both procedures by residents was evaluated as well. Results: In the 257 patients, surgical residents performed 105 laparoscopic and 118 small-incision cholecystectomies. There were no significant differences in complications, conversion rates, and hospital stay. Operative time was significantly shorter with the small-incision technique. Conclusions: No differences in primary clinical outcome measures were found between laparoscopic and small-incision cholecystectomy in this randomized trial with emphasis on methodologic quality and generalizability. The gold standard status of laparoscopic cholecystectomy is questionable. Trial Registration: isrctn.org Identifier: ISRCTN67485658.