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Clinical Trials/NCT01639118
NCT01639118
Terminated
Not Applicable

Prospective Observational Cohort Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias

Algemeen Ziekenhuis Maria Middelares1 site in 1 country11 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventral Hernia
Sponsor
Algemeen Ziekenhuis Maria Middelares
Enrollment
11
Locations
1
Status
Terminated
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
August 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Algemeen Ziekenhuis Maria Middelares
Responsible Party
Principal Investigator
Principal Investigator

Stijn De Sutter

Dr. Stijn De Sutter

Algemeen Ziekenhuis Maria Middelares

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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