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

This study has been completed.
Sponsor:
Collaborator:
Cook Biotech Incorporated
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00647569
First received: March 26, 2008
Last updated: September 6, 2013
Last verified: September 2013
  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:


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 ]

Enrollment: 59
Study Start Date: April 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, Denmark, 8000
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: University of Aarhus
ClinicalTrials.gov Identifier: NCT00647569     History of Changes
Other Study ID Numbers: VRAM M-20070240
Study First Received: March 26, 2008
Last Updated: September 6, 2013
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
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014