Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome
- Registration Number
- NCT02869984
- Lead Sponsor
- Seoul National University Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Ramosetron ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer
- Primary Outcome Measures
Name Time Method low anterior resection syndrome score 4 weeks questionnaire with comparison of frequency or urgency
- Secondary Outcome Measures
Name Time Method Quality of Life score 4 weeks EORTC QLQ C30 (Korean version, validated)