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Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

Primary Purpose

Ventral Hernia

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Laparoscopic Ventral hernia repair by heavy weight mesh
Laparoscopic Ventral hernia repair by lighter weight mesh
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

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

Inclusion Criteria:

  • written informed consent from the patient or his/her legal representative
  • ventral hernia requiring elective surgical repair

Exclusion Criteria:

  • no written informed consent
  • 'hostile' abdomen; open abdomen treatment
  • contraindication to pneumoperitoneum
  • emergency surgery (incarcerated hernia)
  • parastomal hernia

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Laparoscopic Ventral hernia repair by heavy weight mesh

Laparoscopic Ventral hernia repair by lighter weight mesh

Outcomes

Primary Outcome Measures

recurrence rate

Secondary Outcome Measures

morbidity rate
quality of life
postoperative pain
long term complication rate

Full Information

First Posted
December 11, 2007
Last Updated
January 25, 2011
Sponsor
University Hospital, Ghent
Collaborators
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT00573105
Brief Title
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Official Title
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
slow inclusion rate
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Ghent
Collaborators
C. R. Bard

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
General - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery Laparoscopic surgery at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm) with or without anchoring transparietal sutures or double crown technique

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Laparoscopic Ventral hernia repair by heavy weight mesh
Arm Title
2
Arm Type
Experimental
Arm Description
Laparoscopic Ventral hernia repair by lighter weight mesh
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Ventral hernia repair by heavy weight mesh
Intervention Description
Laparoscopic Ventral hernia repair by heavy weight mesh
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Ventral hernia repair by lighter weight mesh
Intervention Description
Laparoscopic Ventral hernia repair by lighter weight mesh
Primary Outcome Measure Information:
Title
recurrence rate
Time Frame
after 1 year
Secondary Outcome Measure Information:
Title
morbidity rate
Time Frame
perioperative
Title
quality of life
Time Frame
after 1 year
Title
postoperative pain
Time Frame
within 1 week
Title
long term complication rate
Time Frame
after 1 year

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 ventral hernia requiring elective surgical repair Exclusion Criteria: no written informed consent 'hostile' abdomen; open abdomen treatment contraindication to pneumoperitoneum emergency surgery (incarcerated hernia) parastomal hernia
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

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Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

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