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Completed

NCT Number: NCT00370344

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.

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Key information

Conditions

Biliary Tract Diseases Calculi Cholecystitis Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Lycksele Hospital, Lycksele, Västerbotten County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.

Small-incision open cholecystectomy

Procedure

Operation by experts in small-incision open cholecystectomy.

Primary outcomes

  1. Health-related quality of life, postoperative pain, and health care costs.

    Time frame: Three, seven, eleven, and 30 postoperative days and one year after the operation.

Secondary outcomes

  1. Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.

    Time frame: Thirty days and one year after the operation.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Norrlandstingens Regionförbund

Registry information

Official study title

An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Aug 31, 2006
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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