Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00572962

Enrollment

210

Registered

2007-12-13

Start date

2008-01-31

Completion date

2014-08-31

Last updated

2022-12-20

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

PROCEDUREuse of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Study design

Allocation

Intervention model

SINGLE_GROUP

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: Mar 20, 2026