Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

Phase 2

Completed

• Conditions: Gallbladder Diseases; Cholecystitis; Biliary Tract Diseases; Cholecystolithiasis
• Interventions: Procedure: Laparoscopic cholecystectomy; Procedure: Small-incision open cholecystectomy

• Registration Number: NCT00370344
• Lead Sponsor: Umeå University

Brief 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.

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Study Start: 2006-09
• Primary Completion: 2011-04
• Study Completion: 2011-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

1. Cholecystectomy is considered the best available treatment.
2. The patient understands trial information and is capable of making a decision after having received information.
3. The patient wants to undergo cholecystectomy and accepts participation in the trial.

Exclusion Criteria

1. Age below 18 years.
2. The patient is unable to understand trial information.
3. Competence for both trial groups are lacking when a patient is randomized.
4. The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
5. The indication of cholecystectomy is proven or suspected cancer of the gallbladder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic cholecystectomy	Laparoscopic cholecystectomy	Operation by experts in laparoscopy.
Small-incision open cholecystectomy	Small-incision open cholecystectomy	Operation by experts in small-incision cholecystectomy.

Primary Outcome Measures

Name	Time	Method
Health-related quality of life, postoperative pain, and health care costs.	Three, seven, eleven, and 30 postoperative days and one year after the operation.

Secondary Outcome Measures

Name	Time	Method
Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.	Thirty days and one year after the operation.

Trial Locations

Locations (2)

Lycksele Hospital; 🇸🇪 Lycksele, Västerbotten, Sweden

Department of Surgery and Perioperative Sciences, Umeå University Hospital; 🇸🇪 Umeå, Västerbotten, Sweden