Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

Umeå University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cholecystitis; Cholecystolithiasis; Gallbladder Diseases; Biliary Tract Diseases

Treatments: Procedure: Laparoscopic cholecystectomy; Procedure: Small-incision open cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00370344

GANO-05-147M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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355 participants in 2 patient groups

Laparoscopic cholecystectomy

Active Comparator group

Description:

Operation by experts in laparoscopy.

Treatment:

Procedure: Laparoscopic cholecystectomy

Small-incision open cholecystectomy

Active Comparator group

Description:

Operation by experts in small-incision cholecystectomy.

Treatment:

Procedure: Small-incision open cholecystectomy