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NCT Number: NCT05577845

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

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

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Key information

Conditions

LARS - Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Low Anterior Resection Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

Location status: Recruiting

Location contact

Seung-Bum Ryoo, MD, PhD

CONTACT

[email protected]

+82-2-2072-7294

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron

Drug

Ramosetron, 4 weeks

Primary outcomes

  1. major Low Anterior Resection Syndrome (LARS)

    Time frame: 0 weeks

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

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

    Time frame: 4 weeks

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

Secondary outcomes

  1. EORTC QLQ-C30 score

    Time frame: 0 weeks

    Quality of life surveillance

  2. EORTC QLQ-C30 score

    Time frame: 4 weeks

    Quality of life surveillance

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: RaLARS

Important dates

Study start
2023
Primary completion
2025
Study completion
2032
First posted
Oct 13, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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