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.
RCT Entities:
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.
Authors: Kamran Ahmed; Tim T Wang; Vanash M Patel; Kamal Nagpal; James Clark; Mariam Ali; Samer Deeba; Hutan Ashrafian; Ara Darzi; Thanos Athanasiou; Paraskevas Paraskeva Journal: Surg Endosc Date: 2010-07-10 Impact factor: 4.584
Authors: Frederik Keus; Trudy de Jonge; Hein G Gooszen; Erik Buskens; Cornelis J H M van Laarhoven Journal: Trials Date: 2009-09-04 Impact factor: 2.279
Authors: Monika E Hagen; Oliver J Wagner; Kari Thompson; Garth Jacobsen; Adam Spivack; Brian Wong; Mark Talamini; Santiago Horgan Journal: J Gastrointest Surg Date: 2009-11-12 Impact factor: 3.452
Authors: Frederik Keus; Jolanda de Vries; Hein G Gooszen; Cornelis J H M van Laarhoven Journal: BMC Gastroenterol Date: 2010-01-27 Impact factor: 3.067