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

Tracking Information

First Received Date ^ICMJE

December 11, 2007

Last Updated Date

April 20, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

recurrence rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00573105 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ventral Hernia

Intervention ^ICMJE

Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh

Study Arms / Comparison Groups

Experimental: Laparoscopic Ventral hernia repair by heavy weight mesh
Experimental: Laparoscopic Ventral hernia repair by lighter weight mesh

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frederik Berrevoet, MD

0032/(0)9/332.48.92

frederik.berrevoet@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00573105

Responsible Party

Frederik Berrevoet, University Hospital Ghent

Study ID Numbers ^ICMJE

2007/421

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

C. R. Bard

Investigators ^ICMJE

Principal Investigator:

Frederik Berrevoet, MD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP