Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias

Terminated

• Conditions: Ventral Hernia; Umbilical Hernia; Epigastric Hernia

• Registration Number: NCT01639118
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

Brief Summary

Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect.

With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-18
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• all adult patients that are planned for surgical repair of a primary umbilical or epigastric hernia will be considered to enter the study.

Exclusion Criteria

• patients refusing to participate at the follow up visits
• pregnancy
• age < 18 years
• life expectancy less than 12 months
• recurrent umbilical or epigastric hernia
• incisional or trocar site hernias
• emergency operations
• liver cirrhosis or ascites
• cancer patients
• concomitant surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Ghent, Oost Vlaanderen, Belgium