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.