NCT02869984

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

August 10, 2016

Last Update Submit

August 12, 2016

Conditions

Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

  • low anterior resection syndrome score

    questionnaire with comparison of frequency or urgency

    4 weeks

Secondary Outcomes (1)

  • Quality of Life score

    4 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Ramosetron

Control

NO INTERVENTION

No treatment

Interventions

RamosetronDRUG
Treatment

Eligibility Criteria

Age19 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who undergo sphincter saving surgery for rectal cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33982068DERIVED

MeSH Terms

Interventions

ramosetron

Central Study Contacts

Kyu Joo Park, MD, PhD

CONTACT

+82-2-2072-2901kjparkmd@plaza.snu.ac.kr

Seung-Bum Ryoo, MD

CONTACT

+82-2-2072-4847sbryoomd@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 17, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2018

Last Updated

August 17, 2016

Record last verified: 2016-08