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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ventral Hernia; Umbilical Hernia; Epigastric Hernia

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Belgium
  • Oost Vlaanderen
    • Ghent, Oost Vlaanderen, Belgium, 9000
      • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

community sample

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Stijn De Sutter, MD, Algemeen ziekenhuis Maria Middelares; Study Director: Filip Muysoms, MD, Algemeen ziekenhuis Maria Middelares; Study Chair: Iris Kyle-Leinhase, PhD, Algemeen ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 18, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: umbilical hernia repair; primary ventral hernia repair with mesh; epigastric hernia repair; C-Qur V-patch; Size tailored repair; preperitoneal repair; abdominal hernia; dual sided mesh
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Hernia, Umbilical
• Other Study ID Numbers: SITUP-2012