Use of a Mesh to Prevent Parastomal Hernia

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

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-02-29

Brief Summary

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Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity

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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

NONE

Study Groups

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1

Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®

Group Type EXPERIMENTAL

Mesh (Ultrapro ®)

Intervention Type DEVICE

In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy

Conventional sigmoid end colostomy

Intervention Type PROCEDURE

Patients receiving conventional sigmoid end colostomy, without mesh

2

Patients receiving conventional sigmoid end colostomy, without mesh

Group Type OTHER

Conventional sigmoid end colostomy

Intervention Type PROCEDURE

Patients receiving conventional sigmoid end colostomy, without mesh

Interventions

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Mesh (Ultrapro ®)

In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy

Intervention Type DEVICE

Conventional sigmoid end colostomy

Patients receiving conventional sigmoid end colostomy, without mesh

Intervention Type PROCEDURE

Other Intervention Names

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Ultrapro ®

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
* Aged over 18,
* Charlson comorbidity index below 7
* Elective surgery
* Radical surgery

Exclusion Criteria

* Loop colostomies,
* Emergency surgery,
* Body mass index above 35 kg/sq.m.,
* Palliative surgery,
* Hepatic cirrhosis,
* Severe COPD (requiring home oxygen treatment),
* Corticoid treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No