Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

Study Overview
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Brief Summary
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In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases. To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception. Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.

Official Title
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Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

Conditions
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Parastomal Hernia, Terminal Colostomy

Intervention / Treatment
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* Device: strattice
* Procedure: No strattice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring a colorectal surgery with a terminal colostomy Elective or emergency surgery Exclusion Criteria: Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI. Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability. Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs Is pregnant, or lactating. Allergic to any porcine or collagen products. survival < 6 months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strattice<br>a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception | Device: strattice<br>* use of a strattice<br>|
| Placebo Comparator: No strattice<br>the colostomy is not reinforced with a mesh | Procedure: No strattice<br>* no use of a strattice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of parastomal hernia | the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan | postoperative month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the pain | The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery | 2 years after the surgery | 
| the postoperative morbidity | the postoperative morbidity will be assessed with the Dindo Clavien classification | postoperative month 1 | 
| the parastomal hernia rate | The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination | postoperative year 1 | 
| the quality of life | The quality of life will be assessed with the STOMA QoL form, the 12-Item Short Form Health Survey (SF12) and the Carolina comfort scale at 1 month, 6 months, 1 year and 2 years after the surgery | 2 years after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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strattice, colostomy, parastomal hernia