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

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ClinicalTrials.gov Identifier: NCT00647569
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : September 9, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Incisional Hernia Pelvic Cancer Procedure: Mesh repair Procedure: Conventional facial closure Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2008
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. incisional hernia formation determined by CT scan 1 year postoperative [ Time Frame: 1 year postoperative ]

Secondary Outcome Measures :
  1. postoperative morbidity [ Time Frame: 30 days postoperative ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00647569     History of Changes
Other Study ID Numbers: VRAM M-20070240
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Incisional Hernia
Pelvic Neoplasms
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Neoplasms by Site
Neoplasms