Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
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.
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.
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.