Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia

Study Overview
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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.

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.

Official Title
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Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach

Conditions
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Parastomal Hernia

Intervention / Treatment
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* Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prophylactic mesh<br>All patients will have a permanent ostomy and a randomisation with prophylactic mesh | Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh<br>* Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh<br>* Other names: PROCEED mesh;|
| No Intervention: without prophylactic mesh<br>All patients will have a permanent ostomy and a randomisation without prophylactic mesh | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done |  | 24 to 36 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the quality of life using the SF-36 |  | Preoperative and at the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parastomal, hernia