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

University Hospital, Ghent110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Ventral Hernia

Interventions

Laparoscopic Ventral hernia repair by heavy weight meshPROCEDURE

Laparoscopic Ventral hernia repair by heavy weight mesh

Laparoscopic Ventral hernia repair by lighter weight meshPROCEDURE

Laparoscopic Ventral hernia repair by lighter weight mesh

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Ghent

Ghent, Belgium

Outcomes

Primary Outcomes

recurrence rate

Time frame: after 1 year

Secondary Outcomes

morbidity rate

Time frame: perioperative

quality of life

Time frame: after 1 year

postoperative pain

Time frame: within 1 week

long term complication rate

Time frame: after 1 year

Data from ClinicalTrials.gov

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