Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 5
- 主要终点
- Evaluation of the quality of bowel preparation by BBPS
研究概览
简要总结
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-patients undergoing a complete colonoscopy
- •Patient written informed consent
排除标准
- •Pregnant or lactating women or at a risk of becoming pregnant
- •Hypersensitivity to any of the ingredients
- •History of anaphylaxis to drugs or allergic reactions in general
- •Known or suspected gastrointestinal obstruction or perforation
- •Toxic megacolon; major colonic resection
- •Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
- •Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
- •Unwillingness to co-operate and to comply with the requirements of the trial
研究组 & 干预措施
2L PEG-CS plus bisacodyl
Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit)
干预措施: 2L PEG-CS plus bisacodyl (Drug)
2L PEG-ASC
Patients will be asked to take PEG-ASC according to labeling instructions
干预措施: 2L PEG-ASC (Drug)
结局指标
主要结局
Evaluation of the quality of bowel preparation by BBPS
时间窗: 20 minutes
BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.
次要结局
- Difference in tolerability between the two groups(24 hours)
- Difference in mucosal visibility between the two groups(20 minutes)
- Number of patients with adverse events(24 hours)
- Difference in patients acceptability between the two groups(24 hours)
- Difference in patients compliance between the two groups(24 hours)