Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch

NCT01761708 | Unknown

• 1 other identifier: Re-situp
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Ventral hernias, such as umbilical, epigastric and trocar-site 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. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.

Conditions

Ventral Hernia; Umbilical Hernia; Epigastric Hernia; Trocar-site 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; trocar-site hernia

Outcome Measures

Primary Outcomes (1)

• mesh infection

  incidence over 12 months

Secondary Outcomes (1)

• hernia recurrence rate

  incidence over 12 months

Study Arms (1)

umbilical, epigastric and trocar-site hernia

Procedure: primary ventral hernia repair with mesh

Interventions

primary ventral hernia repair with mesh PROCEDURE

umbilical, epigastric and trocar-site hernia

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 umbilical, epigastric or trocar-site 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 emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Umbilical; Hernia, Abdominal

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

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
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Stijn De Sutter

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 7, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

BE (1)