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Primary and Clinical Outcomes

Frederik Keus, MD; Johanna E. M. Werner, MD, PhD; Hein G. Gooszen, MD, PhD; Henk J. M. Oostvogel, MD, PhD; Cornelis J. H. M. van Laarhoven, MD, PhD

Arch Surg. 2008;143(4):371-377.

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

Author Affiliations: Department of Surgery, St Elisabeth Hospital, Tilburg, the Netherlands (Drs Keus, Werner, Oostvogel, and van Laarhoven); and Department of Surgery, University Medical Centre, Utrecht, the Netherlands (Dr Gooszen). Dr Keus is now with the Department of Surgery, Diakonessenhuis, Utrecht; Dr Werner is now with the Department of Surgery, University Medical Centre St Radboud, Nijmegen, the Netherlands.

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Randomized Clinical Trial of Small-Incision and Laparoscopic Cholecystectomy in Patients With Symptomatic Cholecystolithiasis: Primary and Clinical Outcomes—Invited Critique
Charles D. Mabry
Arch Surg. 2008;143(4):377-378.
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