Trial record 1 of 278 for:    "Gallbladder Diseases"
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Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Umeå University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Norrlandstingens Regionförbund
Information provided by (Responsible Party):
Markku Haapamaki, Umeå University
ClinicalTrials.gov Identifier:
NCT00370344
First received: August 30, 2006
Last updated: October 26, 2011
Last verified: October 2011
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ 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 Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopy
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.
Active Comparator: Small-incision
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370344

Locations
Sweden
Department of Surgery, Umeå University Hospital
Umeå, Västerbotten, Sweden, SE 90185
Sponsors and Collaborators
Umeå University
Norrlandstingens Regionförbund
Investigators
Study Chair: Peter Naredi, MD, PhD Umeå University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markku Haapamaki, Associate professor, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT00370344     History of Changes
Other Study ID Numbers: GANO-05-147M
Study First Received: August 30, 2006
Last Updated: October 26, 2011
Health Authority: Sweden: The National Board of Health and Welfare

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

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

ClinicalTrials.gov processed this record on August 20, 2014