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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00647569

Acronym

VRAM

Enrollment

Registered

2008-03-31

Start date

2008-04-30

Completion date

2012-06-30

Last updated

2013-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia, Pelvic Cancer

Keywords

vertical rectus abdominis musculocutaneus flap, mesh repair, salvage surgery

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.

Interventions

PROCEDUREMesh repair

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.

PROCEDUREConventional facial closure

The abdominal facia is closed with with continuous running suture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
incisional hernia formation determined by CT scan 1 year postoperative	1 year postoperative

Secondary

Measure	Time frame
postoperative morbidity	30 days postoperative

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026