Prevention of Parastomal Hernia With a Mesh

April 15, 2008 updated by: Sundsvall Hospital

Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Study Overview

Status

Completed

Conditions

Parastomal Hernia

Intervention / Treatment

Procedure: Prophylactic mesh

Detailed Description

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.

A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.

Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.

Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 4

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

Sweden
- - Sundsvall, Sweden, SE-85186
    - Kirurgkliniken Sundsvalls sjukhus

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical need of an enterostoma

Exclusion Criteria:

Patients denies inclusion in the trial.

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 Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound infection,mesh infection, parastomal hernia. Time Frame: Within five years	Within five years

Secondary Outcome Measures

Outcome Measure	Time Frame
Fistula formation, stenosis,pain. Time Frame: Within five years	Within five years

Collaborators and Investigators

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

Sponsor

Sundsvall Hospital

Investigators

Study Director: Leif A Israelsson, MD,PhD, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.

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

January 1, 2001

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria