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Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome

Primary Purpose

Anterior Resection Syndrome

Status
Unknown status
Phase
Early Phase 1
Locations
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 Anterior Resection Syndrome

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients who undergo sphincter saving surgery for rectal cancer

Exclusion Criteria:

  • recurred rectal cancer
  • rectal cancer with distant metastasis
  • permanent stoma formation
  • postoperative concurrent chemoradiotherapy
  • uncontrolled medical disease
  • inflammatory bowel disease
  • uncontrolled constipation
  • preoperative incontinence (LARS score, more than 20)
  • allergic to intervention drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment

    Control

    Arm Description

    ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer

    No treatment

    Outcomes

    Primary Outcome Measures

    low anterior resection syndrome score
    questionnaire with comparison of frequency or urgency

    Secondary Outcome Measures

    Quality of Life score
    EORTC QLQ C30 (Korean version, validated)

    Full Information

    First Posted
    August 10, 2016
    Last Updated
    August 12, 2016
    Sponsor
    Seoul National University Hospital
    Collaborators
    Dong-A ST
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02869984
    Brief Title
    Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Dong-A ST

    4. Oversight

    5. Study Description

    Brief Summary
    Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency. We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Ramosetron
    Primary Outcome Measure Information:
    Title
    low anterior resection syndrome score
    Description
    questionnaire with comparison of frequency or urgency
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of Life score
    Description
    EORTC QLQ C30 (Korean version, validated)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients who undergo sphincter saving surgery for rectal cancer Exclusion Criteria: recurred rectal cancer rectal cancer with distant metastasis permanent stoma formation postoperative concurrent chemoradiotherapy uncontrolled medical disease inflammatory bowel disease uncontrolled constipation preoperative incontinence (LARS score, more than 20) allergic to intervention drug
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kyu Joo Park, MD, PhD
    Phone
    +82-2-2072-2901
    Email
    kjparkmd@plaza.snu.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seung-Bum Ryoo, MD
    Phone
    +82-2-2072-4847
    Email
    sbryoomd@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33982068
    Citation
    Ryoo SB, Park JW, Lee DW, Lee MA, Kwon YH, Kim MJ, Moon SH, Jeong SY, Park KJ. Anterior resection syndrome: a randomized clinical trial of a 5-HT3 receptor antagonist (ramosetron) in male patients with rectal cancer. Br J Surg. 2021 Jun 22;108(6):644-651. doi: 10.1093/bjs/znab071.
    Results Reference
    derived

    Learn more about this trial

    Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome

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