Effects of stoma discharge reinfusion on low anterior resection syndrome and the gut microbiota following sphincter-preserving surgery for middle and low rectal cancer: a randomized clinical trial.

Low anterior resection syndrome (LARS) is a disorder of bowel function that develops after sphincter-preserving surgery for rectal cancer. Transanal irrigation is a treatment for low anterior resection syndrome. This is a single-center prospective randomized controlled trial comparing stoma discharge reinfusion versus standard care 1 month following sphincter-preserving and temporary loop ileostomy surgery was performed. The primary endpoint was the proportion of patients with major LARS at 6 months after ileostomy reversal. Secondary endpoints included Glazer pelvic floor muscle (PFM) surface electromyography (SEMG) and microbiota analysis at 1 month after ileostomy reversal and Quality-of-Life Questionnaire Core 30 (QLQ C30) analysis during follow-up period. Of 60 randomized patients, 52 were included in the analysis (reinfusion group, n = 28; standard care group n = 24). The proportion of patients with major LARS was statistically lower after stoma discharge reinfusion compared with standard care at 6 months after ileostomy reversal (10.7% vs 41.7%, p = 0.01). Glazer PFM SEMG values were significantly higher 1 week prior to ileostomy reversal: phasic contractions (p = 0.04), tonic contractions (p = 0.02), and endurance contractions (p = 0.002); but there were no significant differences at 1 month after ileostomy reversal. QLQ C30 questionnaire showed higher functional scores, but symptom scores and global health status did not improve. Microbiota analysis revealed no significant differences in either beta or alpha diversity. Nevertheless, differentially abundant species were identified between LARS and no-LARS groups. Stoma discharge reinfusion reduced LARS severity and improved anal function and microbiota dysbiosis in patients who underwent sphincter-preserving surgery.Registration number and date of registration NCT05461248, 2022-07-14 ( http://www.clinicaltrials.gov ).