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Clinical Trials/NCT00647569
NCT00647569
Completed
Phase 3

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

University of Aarhus1 site in 1 country59 target enrollmentApril 2008
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ConditionsIncisional HerniaPelvic Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Incisional Hernia
Sponsor
University of Aarhus
Enrollment
59
Locations
1
Primary Endpoint
incisional hernia formation determined by CT scan 1 year postoperative
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
June 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

incisional hernia formation determined by CT scan 1 year postoperative

Time Frame: 1 year postoperative

Secondary Outcomes

  • postoperative morbidity(30 days postoperative)

Study Sites (1)

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