Back to resultsCOMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL) (COMPAC)
Primary Purpose
Incisional Hernia
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
complete repair
partial repair of the abdominal wall
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia
Eligibility Criteria
Inclusion Criteria:
- Written informed consent from the patient or his/her legal representative
- Incisional hernia requiring elective surgical repair
Exclusion Criteria:
- No written informed consent
- Emergency surgery (incarcerated hernia)
- All incisional or parastomal hernias not originating at the midline
- All recurrent hernias
- All patients with mesh placed intra-abdominally during surgery have to be withdrawn
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
recurrence rate
Secondary Outcome Measures
Perioperative morbidity rate
Postoperative pain
Long term complication rate
Recurrence rate
Full Information
NCT ID
NCT00498810
First Posted
July 9, 2007
Last Updated
January 27, 2011
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00498810
Brief Title
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
Acronym
COMPAC
Official Title
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
patients had to be converted to the other study arm
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
complete repair
Intervention Type
Procedure
Intervention Name(s)
partial repair of the abdominal wall
Primary Outcome Measure Information:
Title
recurrence rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Perioperative morbidity rate
Title
Postoperative pain
Title
Long term complication rate
Title
Recurrence rate
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent from the patient or his/her legal representative
Incisional hernia requiring elective surgical repair
Exclusion Criteria:
No written informed consent
Emergency surgery (incarcerated hernia)
All incisional or parastomal hernias not originating at the midline
All recurrent hernias
All patients with mesh placed intra-abdominally during surgery have to be withdrawn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
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