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

Seoul National University Hospital212 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

212

Conditions

LARS - Low Anterior Resection Syndrome

Interventions

RamosetronDRUG

Ramosetron, 4 weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Jongro-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

major Low Anterior Resection Syndrome (LARS)

LARS score (0-20, no, 21-29, minor, 30-42, major)

Time frame: 0 weeks

Difference of improvement of major Low Anterior Resection Syndrome (LARS)

LARS score (0-20, no, 21-29, minor, 30-42, major)

Time frame: 4 weeks

Secondary Outcomes

EORTC QLQ-C30 score

Quality of life surveillance

Time frame: 0 weeks

EORTC QLQ-C30 score

Quality of life surveillance

Time frame: 4 weeks

Data from ClinicalTrials.gov

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