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

NCT ID: NCT00573105

Last Updated: 2011-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-11-30

Brief Summary

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1. General

\- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
2. 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

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Laparoscopic Ventral hernia repair by heavy weight mesh

Group Type EXPERIMENTAL

Laparoscopic Ventral hernia repair by heavy weight mesh

Intervention Type PROCEDURE

Laparoscopic Ventral hernia repair by heavy weight mesh

2

Laparoscopic Ventral hernia repair by lighter weight mesh

Group Type EXPERIMENTAL

Laparoscopic Ventral hernia repair by lighter weight mesh

Intervention Type PROCEDURE

Laparoscopic Ventral hernia repair by lighter weight mesh

Interventions

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Laparoscopic Ventral hernia repair by heavy weight mesh

Laparoscopic Ventral hernia repair by heavy weight mesh

Intervention Type PROCEDURE

Laparoscopic Ventral hernia repair by lighter weight mesh

Laparoscopic Ventral hernia repair by lighter weight mesh

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Frederik Berrevoet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2007/421

Identifier Type: -

Identifier Source: org_study_id

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