Incisional Hernia After Diverting Stoma Closure
Conditions
Keywords
Incisional hernia, Stoma, rectal cancer, synthetic mesh, biologic mesh
Brief summary
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
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.
Interventions
DEVICEBiologic Mesh
Biologic mesh placed in retromuscular position during ileostoma closure
DEVICESynthetic Mesh
synthetic mesh placed in retromuscular position during ileostoma closure
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Biologic mesh Synthetic mesh
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiological incisional hernia rate | up to 36 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 36 months | Score Brief Pain Inventory |
| Postoperative rehospitalization | 36 months | Case report form data |
| Postoperative morbidity | 30 days | Postoperative morbidity |
| Quality of life (The Short Form (36) Health Survey score) | 12 months | The Short Form (36) Health Survey |
| Clinical incisional hernia rate | 36 months | Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient |
| Postoperative reintervention | 36 months | Case report form data |
Countries
France
Outcome results
None listed