Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
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|ClinicalTrials.gov Identifier: NCT00370344|
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Diseases Gallbladder Diseases Cholecystitis Cholecystolithiasis||Procedure: Laparoscopic cholecystectomy Procedure: Small-incision open cholecystectomy||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||355 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||November 2011|
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.
- 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. ]
- 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. ]
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
|Lycksele, Västerbotten, Sweden|
|Department of Surgery and Perioperative Sciences, Umeå University Hospital|
|Umeå, Västerbotten, Sweden, SE 90185|
|Principal Investigator:||Markku M Haapamäki, MD, PhD||Umeå University|
|Principal Investigator:||Mats Rosenmüller, MD||Umeå University|