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

Primary Purpose

LARS - Low Anterior Resection Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LARS - Low Anterior Resection Syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ramosetron

Loperamide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

EORTC QLQ-C30 score
Quality of life surveillance
EORTC QLQ-C30 score
Quality of life surveillance

Full Information

First Posted
September 28, 2022
Last Updated
April 24, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05577845
Brief Title
5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)
Acronym
RaLARS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LARS - Low Anterior Resection Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ramosetron
Arm Type
Experimental
Arm Title
Loperamide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Intervention Description
Ramosetron, 4 weeks
Primary Outcome Measure Information:
Title
major Low Anterior Resection Syndrome (LARS)
Description
LARS score (0-20, no, 21-29, minor, 30-42, major)
Time Frame
0 weeks
Title
Difference of improvement of major Low Anterior Resection Syndrome (LARS)
Description
LARS score (0-20, no, 21-29, minor, 30-42, major)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
EORTC QLQ-C30 score
Description
Quality of life surveillance
Time Frame
0 weeks
Title
EORTC QLQ-C30 score
Description
Quality of life surveillance
Time Frame
4 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongro-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Bum Ryoo, MD, PhD
Phone
+82-2-2072-7294
Email
sbryoomd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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