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

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 outcome 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.