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

Abstract

Introduction: Abdominoperineal resections performed for anorectal tumours leave a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40%-60%). Biological meshes offer possibilities for new standards of perineal wound reconstruction. Perineal fillings with biological mesh are expected to increase quality of life by reducing perineal morbidity.

Methods and analysis: This is a multicentre, randomised and single-blinded study with a blinded endpoint evaluation, the experimental arm of which uses a biological mesh and the control arm of which is defined by the primary closure after abdominoperineal resection for cancer. Patients eligible for inclusion are patients with a proven history of rectal adenocarcinoma and anal canal epidermoid carcinoma for whom abdominoperineal resection was indicated after a multidisciplinary team discussion. All patients must have social security insurance or equivalent social protection. The main objective is to assess the incremental cost-utility ratio (ICUR) of two strategies of perineal closure after an abdominoperineal resection performed for anorectal cancer treatment: perineal filling with biological mesh versus primary perineal closure (70 patient in each arm). The secondary objectives focus on quality of life and morbidity data during a 1-year follow-up. Deterministic and probabilistic sensitivity analyses will be performed in order to estimate the uncertainty surrounding the ICUR. CIs will be constructed using the non-parametric bootstrap approach. A cost-effectiveness acceptability curve will be built so as to estimate the probability of efficiency of the biological meshes given a collective willingness-to-pay threshold.

Ethics and dissemination: The study was approved by the Regional Ethical Review Board of 'Nord Ouest 1' (protocol reference number: 20.05.14.60714; national number: 2020-A01169-30).The results will be disseminated through conventional scientific channels.

Trial registration number: ClinicalTrials.gov Registry (NCT02841293).

Keywords: colorectal surgery; health economics; oncology; wound management.

Figure 1

Study flow chart. ECOG, Eastern Cooperative Oncology Group.

Figure 2

The pelvic floor seen from below during reconstruction with a Cellis biological mesh. The mesh is sutured anteriorly (A) to the transverse perineal muscle (*), laterally (B, C) the mesh is attached to the remaining of the levator complex (black arrows) and at each side of the coccyx or distal sacrum (Δ) with Prolene or polydioxanone sutures (D).

Figure 3

Outcomes summary. PI-NRS, Pain Intensity Numerical Rating Scale.

Figure 4

Flow chart for transmission of healthcare consumption data. *Health insurance ID or NIR for registration number to the listing. **Emergency Regional Observatory of Occitanie. ***Patients identified with their anonymity number. CNAM, Caisse Nationale de l'assurance Maladie et des travailleurs salariés; HDNS, Health Data National System; HEU, health economic unit; NHI, National Health Insurance; SNDS, Système National des Données de Santé.