NCT00370344

Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.

Detailed description

Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. However, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached. Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.

Conditions

• Biliary Tract Diseases
• Gallbladder Diseases
• Cholecystitis
• Cholecystolithiasis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic cholecystectomy	Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
PROCEDURE	Small-incision open cholecystectomy	Operation by experts in small-incision open cholecystectomy.

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-04-01
• Completion: 2011-11-01
• First posted: 2006-08-31
• Last updated: 2015-04-24

Locations

2 sites across 1 country: Sweden