Prevention of Parastomal Hernia With a Mesh

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parastomal Hernia

Keywords

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Parastomal hernia, wound infection, stoma care.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Prophylactic mesh

A low weigth partly absorbable mesh in a subaly posistion

Intervention Type PROCEDURE

Other Intervention Names

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Vypro mesh, Ethicon.

Eligibility Criteria

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Inclusion Criteria

* Clinical need of an enterostoma

Exclusion Criteria

* Patients denies inclusion in the trial.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Leif A Israelsson, MD,PhD

Role: STUDY_DIRECTOR

Umea University

Locations

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Kirurgkliniken Sundsvalls sjukhus

Sundsvall, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT

PMID: 15613293 (View on PubMed)

Other Identifiers

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Preventing parastomal hernia

Identifier Type: -

Identifier Source: org_study_id