Brief Title
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
Official Title
An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
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 Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Health-related quality of life, postoperative pain, and health care costs.
Secondary Outcome
Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.
Condition
Biliary Tract Diseases
Intervention
Laparoscopic cholecystectomy
Study Arms / Comparison Groups
Laparoscopic cholecystectomy
Description: Operation by experts in laparoscopy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
355
Start Date
September 2006
Completion Date
November 2011
Primary Completion Date
April 2011
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Markku M Haapamäki, MD, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT00370344
Organization ID
GANO-05-147M
Responsible Party
Sponsor
Study Sponsor
Umeå University
Collaborators
Norrlandstingens Regionförbund
Study Sponsor
Markku M Haapamäki, MD, PhD, Principal Investigator, Umeå University
Verification Date
April 2015