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Clinical Trials/NCT00647569
NCT00647569CompletedPhase 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 Aarhus2 sites in 1 country59 target enrollmentStarted: April 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
59
Locations
2
Primary Endpoint
incisional hernia formation determined by CT scan 1 year postoperative
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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