RESUMEN
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).
Asunto(s)
Neoplasias del Ano , Carcinoma , Proctectomía , Neoplasias del Recto , Neoplasias del Ano/cirugía , Humanos , Estudios Multicéntricos como Asunto , Perineo/cirugía , Complicaciones Posoperatorias , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias del Recto/cirugía , Mallas QuirúrgicasRESUMEN
OBJECTIVE: Capacitance imaging is a new technique using sensors based on silicon technology developed to record fingerprints for security reasons. Applying such a sensor onto the skin surface gives the capacitance (hydration) map of the skin surface with a two-dimensional resolution of 50 microm. This method was used to characterize skin of the chests of 64 women with various grades of skin photoaging. METHOD: The severity of photoaging of the chest skin of 64 women was clinically assessed according to a six-grade scale. Capacitance images of the skin were recorded and analyzed in terms of mean capacitance, homogeneity of gray levels and density of microrelief lines. Capacitance images of the adjacent unexposed area (upper part of the breast) were also recorded and analyzed for comparison. Pictures of the different areas were recorded. RESULTS: Microrelief line density decreases with the age of the volunteers but is independent of the severity of photoaging. Mean hydration of the skin surface is found to be independent of both photoaging severity and age. Evenness of hydration is a parameter markedly linked to the severity of photoaging independent of age. Uneven hydration is related to the juxtaposition of both hydrated and dry areas corresponding to some hyperpigmented and hyperkeratosic areas. Moreover, capacitance images reveal that some of the hyperpigmented areas may exhibit under- or over-hydrated conditions depending on the nature of the lesion. CONCLUSION: Irregular skin surface hydration is an important characteristic of skin photoaging. It is related to skin pigmentation but does not parallel its unevenness of pigmentation.