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Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Incisional Hernia, Pelvic Cancer

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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

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