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

September 6, 2013 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
No previous major abdominal surgery
Procedure: Mesh 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.
Other Names:
  • Surgisis Gold Hernia repair graft
Procedure: Conventional facial closure
The abdominal facia is closed with with continuous running suture
Experimental: B
Previous major abdominal surgery
Procedure: Mesh 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.
Other Names:
  • Surgisis Gold Hernia repair graft
Procedure: Conventional facial closure
The abdominal facia is closed with with continuous running suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incisional hernia formation determined by CT scan 1 year postoperative
Time Frame: 1 year postoperative
1 year postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative morbidity
Time Frame: 30 days postoperative
30 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Cook Biotech Incorporated

Investigators

  • Principal Investigator: Peter Christensen, M.D., Ph.d, Department of Surgery P, Aarhus University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRAM M-20070240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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