Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 14, 2015
Trial Information
Current as of September 28, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Clichy, France
Patients applied
Trial Officials
Leon Maggiori, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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