Actively Recruiting
Safety and Efficacy of 5-HT3 Receptor Antagonist Ramosetron Versus Loperamide for Treating Low Anterior Resection Syndrome: Multicenter Randomized Controlled Trial
Led by Seoul National University Hospital · Updated on 2023-04-25
212
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mid or low rectal cancer (anorectal verge less than 15 cm)
- Stage II or III rectal cancer with preoperative long-course chemoradiotherapy followed by ileostomy repair
- Between 1 and 12 months after rectal operation without stoma
- Between 1 and 6 months after ileostomy repair
- Presence of major Low Anterior Resection Syndrome (LARS)
You will not qualify if you...
- Recurrent rectal cancer
- Stage IV rectal cancer
- Inflammatory bowel disease (IBD)
- Uncontrolled fecal incontinence or constipation before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either Ramosetron or Loperamide to treat Low Anterior Resection Syndrome.
Visits at the start and end of treatment
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongro-gu, South Korea, 03080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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