Prevention of Parastomal Hernia by Primary Mesh Insertion

February 6, 2014 updated by: Ismail Gögenur, University Hospital, Gentofte, Copenhagen

Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copebhagen
      • Hvidovre, Copebhagen, Denmark, 2630
        • Copenhagen University Hospital, Hvidovre
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Copenhagen University hospital, Gentofte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

  • ASA > 3
  • Acute surgery
  • Known immune deficiency
  • Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
  • Pregnancy
  • Known inflammatory bowel disease
  • Lack of written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: onlay mesh
Device: onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
ACTIVE_COMPARATOR: sublay mesh
Device: onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
NO_INTERVENTION: no mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parastomal hernia verified by CT-scan
Time Frame: one year after surgery, reassessed after 2, 3 and 5 years
one year after surgery, reassessed after 2, 3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinically detected parastomal hernia
Time Frame: one year after surgery, reassessed after 2, 3 and 5 years
one year after surgery, reassessed after 2, 3 and 5 years
Pain
Time Frame: one year after surgery, reassessed after 2, 3 and 5 years
one year after surgery, reassessed after 2, 3 and 5 years
Disease specific and general health questionnaire
Time Frame: one year after surgery, reassessed after 2, 3 and 5 years
one year after surgery, reassessed after 2, 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Zealand University Hospital
Aarhus University Hospital
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Vejle Hospital
Hillerod Hospital, Denmark
Hospital of South West Jutland

Investigators

  • Principal Investigator: Ismail Gögenur, University Hospital of Copenhagen, GEntofte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (ESTIMATE)

March 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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