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CompletedNCT00647569VRAMUpdated Sep 9, 2013

Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer

A Phase 3 interventional study of Mesh repair and Conventional facial closure in Incisional Hernia and Pelvic Cancer, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-09.

Sponsored by University of Aarhus · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Incisional Hernia
  • Pelvic Cancer

Keywords

  • vertical rectus abdominis musculocutaneus flap
  • mesh repair
  • salvage surgery
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In context

Pelvic Neoplasms

98 studies on the registry are indexed under Pelvic Neoplasms; 27 are open to participants now.

This study's enrollment of 59 is above the median of 42 across 63 interventional studies indexed under Pelvic Neoplasms.

Browse Pelvic Neoplasms studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    A

    No previous major abdominal surgery

    Procedure: Mesh repair · Procedure: Conventional facial closure

  • Experimental
    B

    Previous major abdominal surgery

    Procedure: Mesh repair · Procedure: Conventional facial closure

Interventions

  • ProcedureMesh repair

    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.

    Also known as: Surgisis Gold Hernia repair graft

  • ProcedureConventional facial closure

    The abdominal facia is closed with with continuous running suture

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What researchers measure

Primary outcomes

  1. incisional hernia formation determined by CT scan 1 year postoperative

    Time frame: 1 year postoperative

Secondary outcomes

  1. postoperative morbidity

    Time frame: 30 days postoperative

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Study locations

1 site
  • Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
    Aarhus, 8000, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00647569
Lead sponsor
University of Aarhus
Collaborators
Cook Biotech Incorporated
Responsible party
Sponsor
First posted
Mar 31, 2008
Start date
Apr 2008
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Sep 9, 2013

Study contacts

Peter Christensen, M.D., Ph.d
principal investigator · Department of Surgery P, Aarhus University Hospital, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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