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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy

Conditions
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Incisional Hernia, Pelvic Cancer

Intervention / Treatment
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* Procedure: Mesh repair
* Procedure: Conventional facial closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>No previous major abdominal surgery | Procedure: Mesh repair<br>* A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.<br>* Other names: Surgisis Gold Hernia repair graft;Procedure: Conventional facial closure<br>* The abdominal facia is closed with with continuous running suture<br>|
| Experimental: B<br>Previous major abdominal surgery | Procedure: Mesh repair<br>* A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.<br>* Other names: Surgisis Gold Hernia repair graft;Procedure: Conventional facial closure<br>* The abdominal facia is closed with with continuous running suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incisional hernia formation determined by CT scan 1 year postoperative |  | 1 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morbidity |  | 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertical rectus abdominis musculocutaneus flap, mesh repair, salvage surgery