Comparing Ramosetron and Loperamide for treating Low Anterior Resection Syndrome
Official title: Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
Run by Seoul National University Hospital · NCT05577845 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 212 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongro-gu) |
| Status | Recruiting |
| Started | March 27, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2032 |
| Registry record updated | April 25, 2023 |
| Trial ID | NCT05577845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with mid and low rectal cancer who have undergone surgery and are experiencing major LARS.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is being tested in this specific context, similar studies using 5-HT3 receptor antagonists for gastrointestinal issues have shown promise.
Who can join: the full rules
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 it's running
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Seoul National University Hospital
Seoul, Jongro-gu, South Korea Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term follow-up of bowel function (LARS) after rectal cancer surgery and neoadjuvant therapy
This project will see how bowel symptoms (LARS) change over time after sphincter-preserving rectal cancer surgery and whether different neoadjuvant treatment schedules affect those symptoms.
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Thread-embedding acupuncture to speed bowel recovery after colorectal cancer surgery.
This trial will test whether adding thread embedding acupuncture (with electroacupuncture) helps adults recover bowel function faster after elective laparoscopic colorectal cancer surgery.
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Intensified follow-up to reduce bowel symptoms and improve life after rectal cancer surgery
We will test whether an intensified follow-up program can reduce LARS symptoms and improve quality of life for people who have had rectal cancer surgery with a protective ileostomy.
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Assessing the effectiveness of low volume transanal irrigation for patients with Low Anterior Resection Syndrome
This study is testing if a new low-volume irrigation method can help adults with Low Anterior Resection Syndrome feel better after rectal cancer surgery compared to standard treatment alone.
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Personalized care pathways for bowel symptoms after rectal cancer treatment
This project will test whether using an electronic bowel diary and quality-of-life questionnaires can identify treatable causes of ongoing bowel problems in people treated for rectal cancer.
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Development of an e-diary for bowel symptoms in rectal cancer patients
This study is trying to create an easy-to-use online diary for rectal cancer patients to track their bowel symptoms after treatment and see how it affects their daily lives.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.