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
Recruitment status was Recruiting
Sponsor:
University of Aarhus
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
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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 ]
| 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