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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Seoul, Jongro Gu, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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