Cholecystitis Clinical Trial
Official title:
An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
Verified date | April 2015 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: The National Board of Health and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 355 |
Est. completion date | November 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Lycksele Hospital | Lycksele | Västerbotten |
Sweden | Department of Surgery and Perioperative Sciences, Umeå University Hospital | Umeå | Västerbotten |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Norrlandstingens Regionförbund |
Sweden,
Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. Review. — View Citation
Harju J, Juvonen P, Eskelinen M, Miettinen P, Pääkkönen M. Minilaparotomy cholecystectomy versus laparoscopic cholecystectomy: a randomized study with special reference to obesity. Surg Endosc. 2006 Apr;20(4):583-6. Epub 2006 Jan 25. — View Citation
Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD006231. Review. — View Citation
Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD006229. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health-related quality of life, postoperative pain, and health care costs. | Three, seven, eleven, and 30 postoperative days and one year after the operation. | No | |
Secondary | Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave. | Thirty days and one year after the operation. | No |
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