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Prevention of Parastomal Hernia by Primary Mesh Insertion

NCT00641342 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-02-07

No results posted yet for this study

Summary

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

Conditions

  • Parastomal Hernia

Interventions

DEVICE

onlay mesh

StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Hillerod Hospital, Denmark

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Ismail Gögenur · University Hospital of Copenhagen, GEntofte

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00641342 on ClinicalTrials.gov