Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01761708
Acronym
Re-SITUP
Enrollment
57
Registered
2013-01-07
Start date
2012-03-31
Completion date
2013-08-31
Last updated
2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epigastric Hernia, Trocar-site Hernia, Umbilical Hernia, Ventral Hernia

Keywords

primary ventral hernia repair with mesh, umbilical hernia repair, epigastric hernia repair, C-Qur V-patch, Size tailored repair, preperitoneal repair, abdominal hernia, dual sided mesh, trocar-site hernia

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.

Interventions

PROCEDUREprimary ventral hernia repair with mesh

Sponsors

Algemeen Ziekenhuis Maria Middelares
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
mesh infectionincidence over 12 months

Secondary

MeasureTime frame
hernia recurrence rateincidence over 12 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026