Status:
COMPLETED
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
Lead Sponsor:
Umeå University
Collaborating Sponsors:
Norrlandstingens Regionförbund
Conditions:
Biliary Tract Diseases
Gallbladder Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
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 cholecy...
Eligibility Criteria
Inclusion
- Cholecystectomy is considered the best available treatment.
- The patient understands trial information and is capable of making a decision after having received information.
- The patient wants to undergo cholecystectomy and accepts participation in the trial.
Exclusion
- Age below 18 years.
- The patient is unable to understand trial information.
- Competence for both trial groups are lacking when a patient is randomized.
- The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
- The indication of cholecystectomy is proven or suspected cancer of the gallbladder.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00370344
Start Date
September 1 2006
End Date
November 1 2011
Last Update
April 24 2015
Active Locations (2)
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1
Lycksele Hospital
Lycksele, Västerbotten County, Sweden
2
Department of Surgery and Perioperative Sciences, Umeå University Hospital
Umeå, Västerbotten County, Sweden, SE 90185