Back to resultsProspective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
Primary Purpose
Gallbladder Disease
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
LESS cholecystectomy
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Disease focused on measuring cholecystectomy, gallbladder, laparoscopy, laparoendoscopic
Eligibility Criteria
Inclusion Criteria:
- gallbladder disease Age: 18-99
Exclusion Criteria:
- intolerance to laparoscopy
Sites / Locations
- University Hospital Geneva
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LESS cholecystectomy
Laparoscopic cholecystectomy
Arm Description
LESS cholecystectomy
Laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
Body image scale
Secondary Outcome Measures
pain VAS
Analgesic requirement
time to return to work
scar scale
Full Information
NCT ID
NCT00961506
First Posted
August 18, 2009
Last Updated
August 18, 2009
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT00961506
Brief Title
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
Official Title
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Disease
Keywords
cholecystectomy, gallbladder, laparoscopy, laparoendoscopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LESS cholecystectomy
Arm Type
Experimental
Arm Description
LESS cholecystectomy
Arm Title
Laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
LESS cholecystectomy
Intervention Description
LESS cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Body image scale
Time Frame
1 months
Secondary Outcome Measure Information:
Title
pain VAS
Time Frame
10 days
Title
Analgesic requirement
Title
time to return to work
Title
scar scale
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gallbladder disease Age: 18-99
Exclusion Criteria:
intolerance to laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Bucher, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
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