Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- low anterior resection syndrome score
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patients who undergo sphincter saving surgery for rectal cancer
排除标准
- •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
研究组 & 干预措施
Treatment
ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer
干预措施: Ramosetron (Drug)
结局指标
主要结局
low anterior resection syndrome score
时间窗: 4 weeks
questionnaire with comparison of frequency or urgency
次要结局
- Quality of Life score(4 weeks)
研究者
Kyu Joo Park
Professor
Seoul National University Hospital