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
About this trial
This is an interventional treatment trial for Anterior Resection Syndrome
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
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
NCT ID
NCT02869984
First Posted
August 10, 2016
Last Updated
August 12, 2016
Sponsor
Seoul National University Hospital
Collaborators
Dong-A ST
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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