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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00573105

Enrollment

110

Registered

2007-12-13

Start date

2008-02-29

Completion date

2010-11-30

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Brief summary

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

Interventions

PROCEDURELaparoscopic Ventral hernia repair by heavy weight mesh

Laparoscopic Ventral hernia repair by heavy weight mesh

PROCEDURELaparoscopic Ventral hernia repair by lighter weight mesh

Laparoscopic Ventral hernia repair by lighter weight mesh

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
recurrence rate	after 1 year

Secondary

Measure	Time frame
morbidity rate	perioperative
quality of life	after 1 year
postoperative pain	within 1 week
long term complication rate	after 1 year

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026