Trial Information
Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
incisional hernia formation determined by CT scan 1 year postoperative
Outcome Time Frame:
1 year postoperative
Safety Issue:
No
Principal Investigator
Peter Christensen, M.D., Ph.d
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Surgery P, Aarhus University Hospital, Denmark
Authority:
Denmark: The Danish National Committee on Biomedical Research Ethics
Study ID:
VRAM M-20070240
NCT ID:
NCT00647569
Start Date:
April 2008
Completion Date:
March 2013
Related Keywords:
- Incisional Hernia
- Pelvic Cancer
- vertical rectus abdominis musculocutaneus flap
- mesh repair
- salvage surgery
- Hernia
- Hernia, Ventral
- Pelvic Neoplasms