Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)
Primary Purpose
Postoperative Pain, Complications, Recurrence
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
incisional hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring operation time, length of hospital stay
Eligibility Criteria
Inclusion Criteria:
- hernia diameter between 3 and 15 cm
- location at the ventral abdominal wall at least 5cm from costae and inguinal area
- indication for elective repair
- age of 18 years or older
- written informed consent.
Exclusion Criteria:
- contraindication for pneumoperitoneum
- an absolute contraindication for general anesthesia
- history of open abdomen treatment
- patients participating in other trials
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
open
laparoscopic
Arm Description
open incisional hernia repair
laparoscopic incisional hernia repair
Outcomes
Primary Outcome Measures
Postoperative pain
Secondary Outcome Measures
Postoperative analgesics use
complications
operation time
length of hospital stay
recurrence
mortality
Full Information
NCT ID
NCT01420757
First Posted
August 18, 2011
Last Updated
August 19, 2011
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01420757
Brief Title
Laparoscopic Versus Open Incisional Hernia Repair
Acronym
COLIBRI
Official Title
Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.
The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Complications, Recurrence
Keywords
operation time, length of hospital stay
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open
Arm Type
Active Comparator
Arm Description
open incisional hernia repair
Arm Title
laparoscopic
Arm Type
Active Comparator
Arm Description
laparoscopic incisional hernia repair
Intervention Type
Procedure
Intervention Name(s)
incisional hernia repair
Intervention Description
Tension-free open or laparoscopic incisional hernia repair
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Postoperative analgesics use
Time Frame
1 week
Title
complications
Time Frame
4 weeks
Title
operation time
Time Frame
1 day
Title
length of hospital stay
Time Frame
4 weeks
Title
recurrence
Time Frame
5 years
Title
mortality
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hernia diameter between 3 and 15 cm
location at the ventral abdominal wall at least 5cm from costae and inguinal area
indication for elective repair
age of 18 years or older
written informed consent.
Exclusion Criteria:
contraindication for pneumoperitoneum
an absolute contraindication for general anesthesia
history of open abdomen treatment
patients participating in other trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.F. Lange, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Versus Open Incisional Hernia Repair
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