Biological Mesh Repair of Complex Hernias in High Risk Patients

Completed

• Conditions: Hernia

• Registration Number: NCT01997619
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.

Detailed Description

Obervational study

Primare outcome: Surgical site occurence

Secondary outcome: Hernia recurrence

Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-06
• Status Verified: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-11-24
• Last Update Submitted: 2013-11-24
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Abdominal wall reconstruction with biological mesh -

Exclusion Criteria

Pregancy,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
surgical site occurence	30 days	Wound infections, redness, seromas, dehiesience at the hernia implant site

Secondary Outcome Measures

Name	Time	Method
hernia recurrence	20 months	Hernia recurrence at the hernia implant site

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark