Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

Study Overview
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Brief Summary
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This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

Detailed Description
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This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer. Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure. Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Official Title
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Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

Conditions
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Incisional Hernia After Diverting Stoma Closure

Intervention / Treatment
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* Device: Biologic Mesh
* Device: Synthetic Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery Signed consent Affiliation to the French social security system Exclusion Criteria: Emergency surgery History of laparotomy before ileostoma closure. Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy Lactating or pregnant woman Allergy to porcine product or collagen-based product. Allergy to polypropylene. Participation to another protocol focusing on ileostoma closure

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
Interventional Model Description: Biologic mesh Synthetic mesh
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biologic Mesh<br>Biologic mesh placed in retromuscular position | Device: Biologic Mesh<br>* Biologic mesh placed in retromuscular position during ileostoma closure<br>|
| Experimental: Synthetic Mesh<br>Synthetic mesh placed in retromuscular position | Device: Synthetic Mesh<br>* synthetic mesh placed in retromuscular position during ileostoma closure<br>|
| No Intervention: No Mesh<br>No mesh | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological incisional hernia rate | Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up. Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | Postoperative morbidity | 30 days | 
| Postoperative pain | Score Brief Pain Inventory | 36 months | 
| Postoperative rehospitalization | Case report form data | 36 months | 
| Postoperative reintervention | Case report form data | 36 months | 
| Quality of life (The Short Form (36) Health Survey score) | The Short Form (36) Health Survey | 12 months | 
| Clinical incisional hernia rate | Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incisional hernia, Stoma, rectal cancer, synthetic mesh, biologic mesh