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.

• Biliary Tract Diseases
• Gallbladder Diseases
• Cholecystitis
• Cholecystolithiasis

• Procedure: Small-incision open cholecystectomy
• Procedure: Laparoscopic cholecystectomy

• Active Comparator: Patients randomized to be operated by experts in laparoscopy.
• Active Comparator: Patients randomized to be operated by experts in small-incision cholecystectomy.

• Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. Review. No abstract available.
• Harju J, Juvonen P, Eskelinen M, Miettinen P, Paakkonen M. Minilaparotomy cholecystectomy versus laparoscopic cholecystectomy: a randomized study with special reference to obesity. Surg Endosc. 2006 Apr;20(4):583-6. Epub 2006 Jan 25.
• Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD006231. Review.
• Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD006229. Review.

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.