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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: December 11, 2007 Last Updated: April 20, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Collaborator:	C. R. Bard
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00573105

Purpose

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

Condition	Intervention
Ventral Hernia	Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-Trial)

Resource links provided by NLM:

MedlinePlus related topics: Hernia

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Secondary Outcome Measures:

morbidity rate [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
quality of life [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
postoperative pain [ Time Frame: within 1 week ] [ Designated as safety issue: No ]
long term complication rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Laparoscopic Ventral hernia repair by heavy weight mesh	Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh Laparoscopic Ventral hernia repair by heavy weight mesh
2: Experimental Laparoscopic Ventral hernia repair by lighter weight mesh	Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh Laparoscopic Ventral hernia repair by lighter weight mesh

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573105

Contacts

Contact: Frederik Berrevoet, MD

0032/(0)9/332.48.92

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD 0032/(0)9/332.48.92 frederik.berrevoet@ugent.be
Principal Investigator: Frederik Berrevoet, MD

Sponsors and Collaborators

University Hospital, Ghent

C. R. Bard

Investigators

Principal Investigator:

Frederik Berrevoet, MD

University Hospital, Ghent

More Information

Additional Information:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Frederik Berrevoet )
Study ID Numbers:	2007/421
Study First Received:	December 11, 2007
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00573105 History of Changes
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Ventral

ClinicalTrials.gov processed this record on November 09, 2009