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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Anterior Resection Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

Control

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ramosetron

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No