NCT05577845招募中不适用
Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- major Low Anterior Resection Syndrome (LARS)
研究概览
简要总结
Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mid and low rectal cancer (AV<15cm)
- •stage II, III, preop long-course CCRT, then ileostomy repair
- •about 1~12 months after operation (no stomy)
- •about 1~6 months after ileostomy repair
- •major LARS
排除标准
- •recurred rectal cancer
- •uncontrolled preoperative fecal incontinence or constipation
研究组 & 干预措施
Ramosetron
Experimental
干预措施: Ramosetron (Drug)
Loperamide
Active Comparator
干预措施: Ramosetron (Drug)
结局指标
主要结局
major Low Anterior Resection Syndrome (LARS)
时间窗: 0 weeks
LARS score (0-20, no, 21-29, minor, 30-42, major)
Difference of improvement of major Low Anterior Resection Syndrome (LARS)
时间窗: 4 weeks
LARS score (0-20, no, 21-29, minor, 30-42, major)
次要结局
- EORTC QLQ-C30 score(4 weeks)
研究者
Ryoo, Seung-Bum
Clinical Associate Professor
Seoul National University Hospital
研究点 (1)
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