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Recruiting NCT05577845

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

No phase Interventional LARS - Low Anterior Resection Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ramosetron.
Who it may be relevant to
Registry conditions: LARS - Low Anterior Resection Syndrome. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Interventions

  • Drug Ramosetron
    Ramosetron, 4 weeks

Primary outcome measures

  • major Low Anterior Resection Syndrome (LARS) [Time frame: 0 weeks]
  • Difference of improvement of major Low Anterior Resection Syndrome (LARS) [Time frame: 4 weeks]
Secondary outcome measures (2)
  • EORTC QLQ-C30 score [Time frame: 0 weeks]
  • EORTC QLQ-C30 score [Time frame: 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT05577845 · 2208-086-1351

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗