This trial is active, not recruiting.

Conditions ventral hernia, umbilical hernia, epigastric hernia, trocar-site hernia
Treatment primary ventral hernia repair with mesh
Sponsor Algemeen Ziekenhuis Maria Middelares
Start date March 2012
End date August 2013
Trial size 57 participants
Trial identifier NCT01761708, Re-situp


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
primary ventral hernia repair with mesh

Primary Outcomes

mesh infection
time frame: incidence over 12 months

Secondary Outcomes

hernia recurrence rate
time frame: incidence over 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch
Principal investigator Stijn De Sutter, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Algemeen Ziekenhuis Maria Middelares.