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

Seoul National University

Status and phase: Unknown; Early Phase 1

Conditions: Anterior Resection Syndrome

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02869984

1604-095-755

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Male

Ages: 19 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

Drug: Ramosetron

Control

No Intervention group

Description:

No treatment