Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02841293
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Eastern Cooperative Oncology Group performance status score of 2 or less
* Histologically proven rectal adenocarcinoma or anal canal epidermoïd carcinoma
* Abdominoperineal resection indication after multidisciplinary team discussion:
* for rectal adenocarcinoma: circumferential MRI margin equal or less than 1 mm from closest tumoral structure and a striated muscular layer (levator ani or external anal sphincter)
* for epidermoid carcinoma: residual or recurrent tumour after chemoradiotherapy.
* Voluntary written informed consent
* Patients with social security insurance or equivalent social protection
Exclusion Criteria:
* T4 tumour needing a surgical extensive resection with reconstruction by a musculocutaneous flap
* Metastasis disease deemed unresectable with curative intent
* Previous pelvic radiotherapy for another disease than the rectal or anal cancer
* Immunosuppressive drugs treatment
* Uncontrolled diabetes (glycosylated hemoglobin (HbA1c) \> 8 % despite adequate therapy)
* Patient under juridical protection.
* Sensitivity to porcine derived products.
* Enrolment in trial with overlapping primary endpoint.
* Pregnant women
* Breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02841293
Study Brief:
Protocol Section:
NCT02841293