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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01639118
Other study ID # SITUP-2012
Secondary ID
Status Terminated
Phase N/A
First received July 10, 2012
Last updated November 18, 2012
Start date March 2012
Est. completion date August 2012

Study information

Verified date November 2012
Source Algemeen Ziekenhuis Maria Middelares
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

Primary ventral hernias, such as umbilical and epigastric 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.

With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date August 2012
Est. primary completion date August 2012
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 primary umbilical or epigastric 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

- recurrent umbilical or epigastric hernia

- incisional or trocar site hernias

- emergency operations

- liver cirrhosis or ascites

- cancer patients

- concomitant surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Belgium AZ Maria Middelares Ghent Oost Vlaanderen

Sponsors (1)

Lead Sponsor Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

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