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

Ventral Hernia Clinical Trial

— SITUP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01639118
• Other study ID #: SITUP-2012
• 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

Related Conditions & MeSH terms

• Epigastric Hernia
• Hernia
• Hernia, Abdominal
• Hernia, Umbilical
• Hernia, Ventral
• Umbilical Hernia
• Ventral Hernia

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,