Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer

Phase 3

Completed

• Conditions: Incisional Hernia; Pelvic Cancer
• Interventions: Procedure: Mesh repair; Procedure: Conventional facial closure

• Registration Number: NCT00647569
• Lead Sponsor: University of Aarhus

Brief Summary

The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Study Start: 2008-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.

Exclusion Criteria

• Pre or perioperative knowledge of disseminated malignancy
• Unable to follow the control program
• Known allergy to pig
• Compromised immune defense
• Artificial heart valve or recent (< 3 months) implanted foreign body
• Age < 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Mesh repair	No previous major abdominal surgery
A	Conventional facial closure	No previous major abdominal surgery
B	Mesh repair	Previous major abdominal surgery
B	Conventional facial closure	Previous major abdominal surgery

Primary Outcome Measures

Name	Time	Method
incisional hernia formation determined by CT scan 1 year postoperative	1 year postoperative

Secondary Outcome Measures

Name	Time	Method
postoperative morbidity	30 days postoperative

Trial Locations

Locations (1)

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark