Methods
enema, colorectal or coloanal anastomosis
This multicentre (7 centres) open-label RCT included patients with a low colorectal or coloanal anastomosis who had major LARS (LARS score at least 30)SOC was delivered by the treating physician to every patient based on a pathway of bowel management, including a low-fibre diet, laxatives and/or loperamide, physiotherapy (biofeedback and pelvic floor retraining), and small-volume enemas (over 150 ml). For patients allocated to TAI, specific education and training was undertaken by a dedicated nurse or the treating physician in a consultation dedicated to patient education. Subsequently, irrigations were administered by the patient daily, starting with a maximum 1-litre enema, with a self-reported diary being used to record daily irrigation efficacy.A minimal difference in LARS score of 7 between the TAI and SOC groups was deemed clinically relevant. Based on data from a previous study