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Completed

NCT Number: NCT00647569

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

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.

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Key information

Conditions

Incisional Hernia Hernia Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Cancer Pelvic Neoplasms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mesh repair

Procedure

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.

Other names: Surgisis Gold Hernia repair graft

Conventional facial closure

Procedure

The abdominal facia is closed with with continuous running suture

Primary outcomes

  1. incisional hernia formation determined by CT scan 1 year postoperative

    Time frame: 1 year postoperative

Secondary outcomes

  1. postoperative morbidity

    Time frame: 30 days postoperative

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Cook Biotech Incorporated

Registry information

Official study title

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

Acronym: VRAM

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 31, 2008
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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