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Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

Primary Purpose

Biliary Tract Diseases, Gallbladder Diseases, Cholecystitis

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Small-incision open cholecystectomy
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Diseases focused on measuring Gallbladder diseases, gallstones, cholecystectomy, minilaparotomy, laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Lycksele Hospital
  • Department of Surgery and Perioperative Sciences, Umeå University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic cholecystectomy

Small-incision open cholecystectomy

Arm Description

Operation by experts in laparoscopy.

Operation by experts in small-incision cholecystectomy.

Outcomes

Primary Outcome Measures

Health-related quality of life, postoperative pain, and health care costs.

Secondary Outcome Measures

Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.

Full Information

First Posted
August 30, 2006
Last Updated
April 23, 2015
Sponsor
Umeå University
Collaborators
Norrlandstingens Regionförbund
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1. Study Identification

Unique Protocol Identification Number
NCT00370344
Brief Title
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
Official Title
An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Norrlandstingens Regionförbund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Diseases, Gallbladder Diseases, Cholecystitis, Cholecystolithiasis
Keywords
Gallbladder diseases, gallstones, cholecystectomy, minilaparotomy, laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Operation by experts in laparoscopy.
Arm Title
Small-incision open cholecystectomy
Arm Type
Active Comparator
Arm Description
Operation by experts in small-incision cholecystectomy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
Intervention Type
Procedure
Intervention Name(s)
Small-incision open cholecystectomy
Intervention Description
Operation by experts in small-incision open cholecystectomy.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku M Haapamäki, MD, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mats Rosenmüller, MD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lycksele Hospital
City
Lycksele
State/Province
Västerbotten
Country
Sweden
Facility Name
Department of Surgery and Perioperative Sciences, Umeå University Hospital
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
SE 90185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15637373
Citation
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.
Results Reference
background
PubMed Identifier
16437283
Citation
Harju 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.
Results Reference
background
PubMed Identifier
17054285
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. doi: 10.1002/14651858.CD006231.
Results Reference
background
PubMed Identifier
17054284
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;2006(4):CD006229. doi: 10.1002/14651858.CD006229.
Results Reference
background
PubMed Identifier
28388942
Citation
Rosenmuller 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.
Results Reference
derived
PubMed Identifier
23640665
Citation
Rosenmuller 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.
Results Reference
derived

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Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

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