Overview

This trial is active, not recruiting.

Condition ventral hernia
Treatment use of a tissue separating mesh (proceed®) in laparoscopic ventral hernia repair
Sponsor University Hospital, Ghent
Collaborator Johnson & Johnson
Start date January 2008
End date August 2015
Trial size 200 participants
Trial identifier NCT00572962, 2007/268

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
use of a tissue separating mesh (proceed®) in laparoscopic ventral hernia repair
use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Primary Outcomes

Measure
recurrence rate
time frame: after 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair
Principal investigator Frederik Berrevoet, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.