Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

Study Overview
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Brief Summary
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This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

Official Title
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Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

Conditions
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Colostomy Stoma, Parastomal Hernia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be affiliated with a health insurance programme Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860) Patient received colostomy 5 years ago Exclusion Criteria: The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study The subject signals opposition to participating in the study The patient is under safeguard of justice or state guardianship The patient is pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with mesh<br>Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation | |
| no mesh<br>colostomy without mesh placement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of parastomal hernia between groups | Percentage patients with parastomal hernia taken from patient medical records | 5 years after colostomy formation | 
| Date of parastomal hernia | Date of parastomal hernia taken from patient records | 5 years after colostomy formation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protrusion around the stoma | Yes/no | 5 years after colostomy formation | 
| Patient reported pain | Yes/no | 5 years after colostomy formation | 
| Occlusion | Yes/no | 5 years after colostomy formation | 
| Incarceration | Yes/no | 5 years after colostomy formation | 
| Patient reported quality of life | Stoma-QoL questionnaire - a 20-item questionnaire on a four-point Likert scale with total score ranging from 0 (worst score) to 100 (best score) | 5 years after colostomy formation | 
| Pain at colostomy site | 0-100 scale (no pain to intolerable pain) | 5 years after colostomy formation | 
| Discomfort | 0-100 scale (very uncomfortable to very comfortable) | 5 years after colostomy formation | 
| Patient reported satisfaction | 0-100 scale (not at all satisfied to very satisfied) | 5 years after colostomy formation | 
| Number of specialist and general consultations attended by patients between groups | number of consultations | 5 years after colostomy formation | 
| Number of medications taken in each group | Number of medications taken | 5 years after colostomy formation | 
| Other associated treatment received by patients in each group | number of treatments received | 5 years after colostomy formation | 
| Rehabilitation sessions undergone by patients in each group | number of rehabilitation sessions | 5 years after colostomy formation | 
| Sick leave taken by patients in each group | Number of days | 5 years after colostomy formation | 
| Cost of patients care | Euros | 5 years after colostomy formation |