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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cook Biotech Incorporated
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00647569
First received: March 26, 2008
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Incisional Hernia
Pelvic Cancer
 Procedure: Mesh repair
Procedure: Conventional facial closure
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hernia
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • incisional hernia formation determined by CT scan 1 year postoperative [ Time Frame: 1 year postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative morbidity [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Surgisis Gold Hernia repair graft
Procedure: Conventional facial closure
The abdominal facia is closed with with continuous running suture

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647569

Contacts
Contact: Peter Christensen, M.D., Ph.D +45 8949 7527 piz@webspeed.dk
Contact: Søren Laurberg, D.M.Sci +45 8949 7715 OVL07SL@as.aaa.dk

Locations
Denmark
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Peter Christensen     +45 8949 7527     piz@webspeed.dk    
Principal Investigator: Peter Christensen            
Sponsors and Collaborators
University of Aarhus
Cook Biotech Incorporated
Investigators
Principal Investigator: Peter Christensen, M.D., Ph.d Department of Surgery P, Aarhus University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Peter Christensen, M.D., Ph.D, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00647569     History of Changes
Other Study ID Numbers: VRAM M-20070240
Study First Received: March 26, 2008
Last Updated: September 3, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
vertical rectus abdominis musculocutaneus flap
mesh repair
salvage surgery

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pelvic Neoplasms
Pathological Conditions, Anatomical
 Hernia, Abdominal
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 13, 2013