Prevention of Parastomal Hernia by Primary Mesh Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Parastomal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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onlay mesh

Group Type ACTIVE_COMPARATOR

onlay mesh

Intervention Type DEVICE

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

sublay mesh

Group Type ACTIVE_COMPARATOR

onlay mesh

Intervention Type DEVICE

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

no mesh

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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onlay mesh

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No