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NCT00572962 Clinical Trial

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

Ventral Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00572962
Other study ID # 2007/268
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2008
Est. completion date August 2014

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Johnson & Johnson

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence rate after 1 year
Secondary morbidity rate perioperative
Secondary quality of life after 1 year
Secondary postoperative pain within 1 week
Secondary long term complication rate after 1 year
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Completed NCT01719718 - The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair N/A
Completed NCT03342040 - Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair N/A
Completed NCT04150796 - Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias N/A
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Completed NCT05610267 - Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Terminated NCT01794338 - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients N/A
Completed NCT01886963 - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair N/A

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