NCT01209806已完成不适用
The Effects of Moviprep With Simethicone on Colonic Bubbles
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Efficacy - Entire colon
研究概览
简要总结
The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.
详细描述
evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid
排除标准
- •Unable or unwilling to give informed consent
- •Age < 18 years
- •Breast feeding
- •Established or suspected gastroparesis
- •Pseudo-obstruction - established or suspected
- •Severe constipation (< 1 BM a week)
- •Bowel obstruction
- •Greater than 50% resection of colon
- •Chronic nausea or vomiting
- •Consumed > 100% standard dose of PEG-ELS (i.e. more than 2L)
- •G6PD deficiency
- •PEG allergy
- •Significant psychiatric illness
研究组 & 干预措施
simethicone
Active Comparator
干预措施: simethicone (Drug)
结局指标
主要结局
Efficacy - Entire colon
时间窗: At time of colonoscopy
Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
次要结局
- Efficacy - Right colon(At time of colonoscopy)
- Adenoma detection(at time of colonoscopy)
- Flushing(at time of colonoscopy)
- Tolerance(during prep ingestion)
- Safety(at time of colonoscopy)
研究者
研究点 (1)
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