Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer
VRAM
Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 9, 2013
September 1, 2013
4.2 years
March 26, 2008
September 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incisional hernia formation determined by CT scan 1 year postoperative
1 year postoperative
Secondary Outcomes (1)
postoperative morbidity
30 days postoperative
Study Arms (2)
A
EXPERIMENTALNo previous major abdominal surgery
B
EXPERIMENTALPrevious major abdominal surgery
Interventions
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.
The abdominal facia is closed with with continuous running suture
Eligibility Criteria
You may qualify if:
- Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Cook Biotech Incorporatedcollaborator
Study Sites (1)
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Christensen, M.D., Ph.d
Department of Surgery P, Aarhus University Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
September 9, 2013
Record last verified: 2013-09