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

NCT01639118 | Terminated

• 1 other identifier: SITUP-2012
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia; Umbilical Hernia; Epigastric Hernia

Keywords

primary ventral hernia repair with mesh; umbilical hernia repair; epigastric hernia repair; C-Qur V-patch; Size tailored repair; preperitoneal repair; abdominal hernia; dual sided mesh

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

• all adult patients that are planned for surgical repair of a primary umbilical or epigastric hernia will be considered to enter the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, Oost Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Umbilical; Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stijn De Sutter, MD

  Algemeen Ziekenhuis Maria Middelares

  PRINCIPAL INVESTIGATOR

• Filip Muysoms, MD

  Algemeen Ziekenhuis Maria Middelares

  STUDY DIRECTOR

• Iris Kyle-Leinhase, PhD

  Algemeen Ziekenhuis Maria Middelares

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Stijn De Sutter

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 20, 2012

Record last verified: 2012-11

Locations

BE (1)