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

NCT01761708 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2013-01-07

No results posted yet for this study

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

PROCEDURE

primary ventral hernia repair with mesh

Sponsors & Collaborators

  • Algemeen Ziekenhuis Maria Middelares

    lead OTHER

Principal Investigators

  • Stijn De Sutter, MD · Algemeen Ziekenhuis Maria Middelares

  • Filip Muysoms, MD · Algemeen Ziekenhuis Maria Middelares

  • Iris Kyle-Leinhase, PhD · Algemeen Ziekenhuis Maria Middelares

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761708 on ClinicalTrials.gov