Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch

• Conditions: Ventral Hernia; Umbilical Hernia; Epigastric Hernia; Trocar-site Hernia
• Interventions: Procedure: primary ventral hernia repair with mesh

• Registration Number: NCT01761708
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

Brief Summary

Ventral hernias, such as umbilical, epigastric and trocar-site 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. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

all adult patients that are planned for surgical repair of a umbilical, epigastric or trocar-site 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 emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
umbilical, epigastric and trocar-site hernia	primary ventral hernia repair with mesh	-

Primary Outcome Measures

Name	Time	Method
mesh infection	incidence over 12 months

Secondary Outcome Measures

Name	Time	Method
hernia recurrence rate	incidence over 12 months

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Belgium