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Small-Incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
This study is ongoing, but not recruiting participants.
First Received: August 30, 2006   Last Updated: November 19, 2008   History of Changes
Sponsors and Collaborators: Umeå University
County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND)
Information provided by: Umeå University
ClinicalTrials.gov Identifier: NCT00370344
  Purpose

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.


Condition Intervention Phase
Biliary Tract Diseases
Gallbladder Diseases
Cholecystitis
Cholecystolithiasis
Procedure: Small-incision open cholecystectomy
Procedure: Laparoscopic cholecystectomy
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: An Expertise-Based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: September 2006
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Laparoscopy: Active Comparator
Patients randomized to be operated by experts in laparoscopy.
Procedure: Laparoscopic cholecystectomy
The operation is performed by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
Small-incision: Active Comparator
Patients randomized to be operated by experts in small-incision cholecystectomy.
Procedure: Small-incision open cholecystectomy
The operation is performed by experts in small-incision open cholecystectomy.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370344

Locations
Sweden, Västerbotten
Department of Surgery, Umeå University Hospital
Umeå, Västerbotten, Sweden, SE 90185
Sponsors and Collaborators
Umeå University
County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND)
Investigators
Study Chair: Peter Naredi, MD, PhD Umeå University
  More Information

Publications:
Responsible Party: Umeå University, Department of Surgery ( Markku Haapamaki MD, PhD )
Study ID Numbers: GANO-05-147M
Study First Received: August 30, 2006
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00370344     History of Changes
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
Gallbladder diseases
gallstones
cholecystectomy
minilaparotomy
laparoscopy

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases
Cholelithiasis
Acalculous Cholecystitis
Gallstones
Biliary Tract Diseases
Cholecystitis
Calculi

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Cholecystolithiasis
Gallbladder Diseases
Digestive System Diseases
Cholelithiasis
Gallstones
Acalculous Cholecystitis
Biliary Tract Diseases
Cholecystitis
Calculi

ClinicalTrials.gov processed this record on July 02, 2009