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

Not Applicable

Recruiting

• Conditions: LARS - Low Anterior Resection Syndrome
• Interventions: Drug: Ramosetron

• Registration Number: NCT05577845
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Study Start: 2023-03-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25
• Primary Completion: 2025-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramosetron	Ramosetron	-
Loperamide	Ramosetron	-

Primary Outcome Measures

Name	Time	Method
major Low Anterior Resection Syndrome (LARS)	0 weeks	LARS score (0-20, no, 21-29, minor, 30-42, major)
Difference of improvement of major Low Anterior Resection Syndrome (LARS)	4 weeks	LARS score (0-20, no, 21-29, minor, 30-42, major)

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30 score	4 weeks	Quality of life surveillance

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongro-gu, Korea, Republic of