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Search / Trial NCT05577845

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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Oct 11, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of two medications, Ramosetron and Loperamide, for treating Low Anterior Resection Syndrome (LARS). LARS is a condition that can occur after surgery for rectal cancer, leading to problems such as frequent bowel movements and difficulty controlling them. The study is looking for participants who have had surgery for mid or low rectal cancer, specifically those who are experiencing significant LARS symptoms 1 to 12 months after their operation or 1 to 6 months after their ileostomy repair.

To be eligible for this trial, participants should be adults with stage II or III rectal cancer who have undergone treatment and are now experiencing major LARS. However, individuals with recurrent rectal cancer, stage IV cancer, inflammatory bowel disease (IBD), or uncontrolled bowel issues before surgery are not eligible. If you decide to join the trial, you can expect to receive one of the two medications and be monitored for how well it helps manage your symptoms. This trial is currently recruiting participants and aims to improve treatment options for those affected by LARS.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • mid and low rectal cancer (AV\<15cm)
  • stage II, III, preop long-course CCRT, then ileostomy repair
  • about 1\~12 months after operation (no stomy)
  • about 1\~6 months after ileostomy repair
  • major LARS
  • Exclusion Criteria:
  • recurred rectal cancer
  • stage IV
  • IBD
  • uncontrolled preoperative fecal incontinence or constipation

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Seoul, , Korea, Republic Of

Seoul, Jongro Gu, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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