Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
1 other identifier
interventional
355
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
August 31, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedApril 24, 2015
April 1, 2015
4.6 years
August 30, 2006
April 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-related quality of life, postoperative pain, and health care costs.
Three, seven, eleven, and 30 postoperative days and one year after the operation.
Secondary Outcomes (1)
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.
Study Arms (2)
Laparoscopic cholecystectomy
ACTIVE COMPARATOROperation by experts in laparoscopy.
Small-incision open cholecystectomy
ACTIVE COMPARATOROperation by experts in small-incision cholecystectomy.
Interventions
Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
Operation by experts in small-incision open cholecystectomy.
Eligibility Criteria
You may qualify if:
- Cholecystectomy is considered the best available treatment.
- The patient understands trial information and is capable of making a decision after having received information.
- The patient wants to undergo cholecystectomy and accepts participation in the trial.
You may not qualify if:
- Age below 18 years.
- The patient is unable to understand trial information.
- Competence for both trial groups are lacking when a patient is randomized.
- The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
- The indication of cholecystectomy is proven or suspected cancer of the gallbladder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- Norrlandstingens Regionförbundcollaborator
Study Sites (2)
Lycksele Hospital
Lycksele, Västerbotten County, Sweden
Department of Surgery and Perioperative Sciences, Umeå University Hospital
Umeå, Västerbotten County, SE 90185, Sweden
Related Publications (6)
Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. doi: 10.1136/bmj.330.7482.88.
PMID: 15637373BACKGROUNDHarju J, Juvonen P, Eskelinen M, Miettinen P, Paakkonen M. Minilaparotomy cholecystectomy versus laparoscopic cholecystectomy: a randomized study with special reference to obesity. Surg Endosc. 2006 Apr;20(4):583-6. doi: 10.1007/s00464-004-2280-6. Epub 2006 Jan 25.
PMID: 16437283BACKGROUNDKeus 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. doi: 10.1002/14651858.CD006231.
PMID: 17054285BACKGROUNDKeus 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;2006(4):CD006229. doi: 10.1002/14651858.CD006229.
PMID: 17054284BACKGROUNDRosenmuller MH, Nilsson E, Lindberg F, Aberg SO, Haapamaki MM. Costs and quality of life of small-incision open cholecystectomy and laparoscopic cholecystectomy - an expertise-based randomised controlled trial. BMC Gastroenterol. 2017 Apr 8;17(1):48. doi: 10.1186/s12876-017-0601-1.
PMID: 28388942DERIVEDRosenmuller MH, Thoren Ornberg M, Myrnas T, Lundberg O, Nilsson E, Haapamaki MM. Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy. Br J Surg. 2013 Jun;100(7):886-94. doi: 10.1002/bjs.9133.
PMID: 23640665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markku M Haapamäki, MD, PhD
Umeå University
- PRINCIPAL INVESTIGATOR
Mats Rosenmüller, MD
Umeå University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2006
First Posted
August 31, 2006
Study Start
September 1, 2006
Primary Completion
April 1, 2011
Study Completion
November 1, 2011
Last Updated
April 24, 2015
Record last verified: 2015-04