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Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370344
First Posted: August 31, 2006
Last Update Posted: April 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norrlandstingens Regionförbund
Information provided by (Responsible Party):
Umeå University
  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: Laparoscopic cholecystectomy Procedure: Small-incision open cholecystectomy Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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. ]

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. ]

Enrollment: 355
Study Start Date: September 2006
Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic cholecystectomy
Operation by experts in laparoscopy.
Procedure: Laparoscopic cholecystectomy
Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
Active Comparator: Small-incision open cholecystectomy
Operation by experts in small-incision cholecystectomy.
Procedure: Small-incision open cholecystectomy
Operation 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370344


Locations
Sweden
Lycksele Hospital
Lycksele, Västerbotten, Sweden
Department of Surgery and Perioperative Sciences, Umeå University Hospital
Umeå, Västerbotten, Sweden, SE 90185
Sponsors and Collaborators
Umeå University
Norrlandstingens Regionförbund
Investigators
Principal Investigator: Markku M Haapamäki, MD, PhD Umeå University
Principal Investigator: Mats Rosenmüller, MD Umeå University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT00370344     History of Changes
Other Study ID Numbers: GANO-05-147M
First Submitted: August 30, 2006
First Posted: August 31, 2006
Last Update Posted: April 24, 2015
Last Verified: April 2015

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

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