NCT02507037已完成4 期
Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy: A Prospective Randomized Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Boston Bowel Preparation Scale
研究概览
简要总结
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of procedure, patients' tolerance, and adverse events were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adults (18-65) who were referred for outpatient colonoscopy.
排除标准
- •under 18 years or More than 65 years
- •previous abdominal surgery
- •major psychiatric disorders
- •pregnancy
- •presence of any contraindications for colonoscopy(eg, severe heart failure)
- •recent inadequate colonoscopy history
研究组 & 干预措施
gum+PEG
Experimental
used 2L PEG+sugarless gum
干预措施: gum+PEG (Dietary Supplement)
PEG
Placebo Comparator
only used 2L PEG
干预措施: polyethylene glycol (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale
时间窗: 2 days
次要结局
- number of patient tolerability(2 days)
- Adenoma Detection Rate(2 days)
- number of patient willingness to repeat preparation(2 days)
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital
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