NCT01761708

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Algemeen Ziekenhuis Maria Middelares · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ventral Hernia
• Umbilical Hernia
• Epigastric Hernia
• Trocar-site Hernia

Interventions

Type	Name	Description
PROCEDURE	primary ventral hernia repair with mesh

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-01-07
• Last updated: 2013-01-07

Locations

1 site across 1 country: Belgium