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

Ventral Hernia Clinical Trial

— Re-SITUP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01761708
• Other study ID #: Re-situp
• Status: Active, not recruiting
• Phase: N/A
• First received: January 3, 2013
• Last updated: January 3, 2013
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2013
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• 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 umbilical, epigastric or trocar-site 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 emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epigastric Hernia
• Hernia
• Hernia, Abdominal
• Hernia, Umbilical
• Hernia, Ventral
• Trocar-site Hernia
• Umbilical Hernia
• Ventral Hernia

Intervention

Procedure:
• primary ventral hernia repair with mesh

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mesh infection		incidence over 12 months	Yes
Secondary	hernia recurrence rate		incidence over 12 months	No