Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study.

摘要: Introduction Abdominoperineal resections performed for anorectal tumours leave a large pelvic and perineal defect causing high rate of morbidity the wound (40%–60%). Biological meshes offer possibilities new standards reconstruction. Perineal fillings with biological mesh are expected to increase quality life by reducing morbidity. Methods analysis This is multicentre, randomised single-blinded study blinded endpoint evaluation, experimental arm which uses control defined primary closure after abdominoperineal resection cancer. Patients eligible inclusion patients proven history rectal adenocarcinoma anal canal epidermoid carcinoma whom was indicated multidisciplinary team discussion. All must have social security insurance or equivalent protection. The main objective assess incremental cost–utility ratio (ICUR) two strategies an cancer treatment: filling versus (70 patient in each arm). secondary objectives focus on data during 1-year follow-up. Deterministic probabilistic sensitivity analyses will be order estimate uncertainty surrounding ICUR. CIs constructed using non-parametric bootstrap approach. A cost-effectiveness acceptability curve built so as probability efficiency given collective willingness-to-pay threshold. Ethics dissemination approved Regional Ethical Review Board ‘Nord Ouest 1’ (protocol reference number: 20.05.14.60714; national 2020-A01169-30). results disseminated through conventional scientific channels. Trial registration number ClinicalTrials.gov Registry (NCT02841293).