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

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Ventral Hernia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00573105

2007/421

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

1

Experimental group

Description:

Laparoscopic Ventral hernia repair by heavy weight mesh

Treatment:

Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh

2

Experimental group

Description:

Laparoscopic Ventral hernia repair by lighter weight mesh

Treatment:

Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh