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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01761708
Other study ID # Re-situp
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 3, 2013
Last updated January 3, 2013
Start date March 2012
Est. completion date August 2013

Study information

Verified date January 2013
Source Algemeen Ziekenhuis Maria Middelares
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 57
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
primary ventral hernia repair with mesh


Locations

Country Name City State
Belgium AZ Maria Middelares Gent

Sponsors (1)

Lead Sponsor Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary mesh infection incidence over 12 months Yes
Secondary hernia recurrence rate incidence over 12 months No
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