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

ConditionLARS - Low Anterior Resection Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

recurred rectal cancer

stage IV

IBD

uncontrolled preoperative fecal incontinence or constipation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ramosetron

    Drug

    Ramosetron, 4 weeks

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: RamosetronExperimental treatment 1 intervention
Group B: LoperamideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

major Low Anterior Resection Syndrome (LARS)

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

Time frame
0 weeks
2

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

1

EORTC QLQ-C30 score

Quality of life surveillance

Time frame
0 weeks
2

EORTC QLQ-C30 score

Quality of life surveillance

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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