• Frederik Keus, Johanna E M Werner, Hein G Gooszen, Henk J M Oostvogel, and Cornelis J H M van Laarhoven.
• Department of Surgery, St Elisabeth Hospital, Tilburg, the Netherlands.
• Arch Surg. 2008 Apr 1; 143 (4): 371-7; discussion 377-8.

ObjectiveTo evaluate the primary and clinical outcomes in laparoscopic and small-incision cholecystectomy.DesignBlinded randomized single-center trial emphasizing methodologic quality and generalizability.SettingGeneral teaching hospital in the Netherlands.PatientsA total of 257 patients undergoing cholecystectomy for symptomatic cholecystolithiasis.InterventionsLaparoscopic cholecystectomy and small-incision cholecystectomy, performed mainly by surgical residents.Main Outcome MeasuresComplications 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.ResultsIn 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.ConclusionsNo 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.

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