Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of 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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

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Detailed Description

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Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.

Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.

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

SINGLE

Outcome Assessors

Study Groups

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Prophylactic mesh

All patients will have a permanent ostomy and a randomisation with prophylactic mesh

Group Type ACTIVE_COMPARATOR

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Intervention Type DEVICE

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

without prophylactic mesh

All patients will have a permanent ostomy and a randomisation without prophylactic mesh

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Intervention Type DEVICE

Other Intervention Names

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PROCEED mesh

Eligibility Criteria

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Inclusion Criteria

* Patients with permanent ostomy and 1 years of life expectancy
* Signed informed consent

Exclusion Criteria

* Allergy to the compounds of the mesh
* Rejection of the patient
* Rejection of the surgeon
* Field of emergency
* Life expectancy \< 1 year
* Prior meshes in the surgical site

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No