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| 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 |
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Biliary Tract Diseases Gallbladder Diseases Cholecystitis Cholecystolithiasis |
Procedure: Small-incision open cholecystectomy Procedure: Laparoscopic cholecystectomy |
Phase II Phase III |
| MedlinePlus related topics: | Gallbladder Diseases Gallstones |
| 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 |
| 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.
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Procedure: Laparoscopic cholecystectomy
The operation is performed by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
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Small-incision: Active Comparator
Patients randomized to be operated by experts in small-incision cholecystectomy.
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Procedure: Small-incision open cholecystectomy
The operation is performed by experts in small-incision open cholecystectomy.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Markku M Haapamäki, MD, PhD | +44 90 7852013 | markku.haapamaki@surgery.umu.se |
| Contact: Anders Sylvan, MD, PhD | +46 90 785 0000 | anders.sylvan@vll.se |
| Sweden, Västerbotten | |||||
| Department of Surgery, Umeå University Hospital | Recruiting | ||||
| Umeå, Västerbotten, Sweden, SE 90185 | |||||
| Contact: Mats Rosenmüller, MD +46-907852962 mats.rosenmuller@telia.se | |||||
| Contact: Fredrik Lindberg, MD +46-907850000 fredrik.lindberg@vll.se | |||||
| Principal Investigator: Markku M Haapamaki, MD, PhD | |||||
| Umeå University |
| County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND) |
| Study Chair: | Peter Naredi, MD, PhD | Umeå University |
More Information
| Responsible Party: | Umeå University, Department of Surgery ( Markku Haapamaki MD, PhD ) |
| Study ID Numbers: | GANO-05-147M |
| First Received: | August 30, 2006 |
| Last Updated: | August 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00370344 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
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