Comparing Safety and Effectiveness of Ramosetron and Loperamide for Treating Low Anterior Resection Syndrome in Rectal Cancer Patients

What this Trial Is About

This research aims to compare the safety and effectiveness of two drugs, Ramosetron and Loperamide, for treating Low Anterior Resection Syndrome LARS, a condition occurring after surgery for mid and low rectal cancer. The study focuses on patients who have undergone surgery and ileostomy repair, assessing improvements in major LARS symptoms. The trial is a multicenter, randomized, and controlled study sponsored by Seoul National University Hospital. Participants will be randomly assigned to receive either Ramosetron or Loperamide. Ramosetron is administered as a drug over a 4-week period. The study uses a quadruple masking design to ensure unbiased results. Both treatments are evaluated over this timeframe to compare their effects on LARS symptoms and patient quality of life. During the study, participants will be assessed at the start and after 4 weeks to measure the severity of major LARS and quality of life using the EORTC QLQ-C30 questionnaire. Researchers will monitor symptom improvement and evaluate safety. The total participation time aligns with these 4-week treatment and assessment periods, focusing on changes in LARS and quality of life scores.

5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)