A Multicenter Study Comparing Transanal Irrigation and Glycerol Suppositories for Treating Severe Low Anterior Resection Syndrome After Rectal Cancer Surgery

What this Trial Is About

Researchers are conducting a multicenter randomized controlled trial to compare two treatments for patients with major Low Anterior Resection Syndrome LARS, a condition affecting bowel function after rectal cancer surgery. The study aims to evaluate whether transanal irrigation TAI or glycerol suppositories provide better relief for LARS symptoms. This Phase 3 trial addresses an important question about managing persistent bowel issues after personalized conservative treatments have failed. The trial randomly assigns patients to one of two groups one receiving daily transanal irrigation using the Qufora Irrisedo Cone System with increasing water volumes over three months, and the other administering a daily glycerol suppository to stimulate bowel movements. Treatment lasts for 12 weeks, with the first month involving 150 ml irrigation, the second month 300 ml, and the third month 500 ml for the TAI group. The glycerol suppository group uses a consistent daily dose throughout. Participants will be monitored closely during the 12-week treatment period, completing various questionnaires and assessments to measure bowel function, urinary and sexual function, quality of life, and health economics. Primary outcomes focus on changes in symptom scores using the Measure Yourself Medical Outcome Profile MYMOP2. Additional evaluations include bowel movement frequency, incontinence episodes, and quality of life surveys, with data collected at multiple time points to track progress and safety throughout the study.

Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome