Comparing Ramosetron and Loperamide for treating Low Anterior Resection Syndrome
Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
This study is testing whether Ramosetron or Loperamide works better to relieve symptoms for people dealing with Low Anterior Resection Syndrome after rectal cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongro-gu) |
| Trial ID | NCT05577845 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Ramosetron, a 5-HT3 receptor antagonist, compared to Loperamide for patients suffering from Low Anterior Resection Syndrome (LARS) following rectal cancer surgery. It is a multicenter randomized controlled trial aimed at determining which treatment provides better symptom relief for patients experiencing major LARS. Participants will be recruited from Seoul National University Hospital and will be monitored for their response to the interventions over a specified period post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with mid and low rectal cancer who have undergone surgery and are experiencing major LARS.
Not a fit: Patients with recurrent rectal cancer, stage IV cancer, inflammatory bowel disease, or uncontrolled preoperative fecal incontinence or constipation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from LARS, improving their quality of life.
How similar studies have performed: While this approach is being tested in this specific context, similar studies using 5-HT3 receptor antagonists for gastrointestinal issues have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Jongro-gu
- Seoul National University Hospital — Seoul, Jongro-gu, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.