A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,044
- 试验地点
- 1
- 主要终点
- Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
研究概览
简要总结
Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy
详细描述
To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects referred to diagnostic or therapeutic colonoscopy
排除标准
- •known or suspected bowel obstruction
- •active bowel inflammation
- •pregnancy
- •any presence of serious medical conditions
- •history of prior colonic or rectal surgery
- •inability to obtain valid data from subject
研究组 & 干预措施
PEG1D
Polyethylene glycols single dose a day before colonoscopy
干预措施: Polyethylene Glycols (Drug)
PEG2D
Polyethylene glycols split dose
干预措施: Polyethylene Glycols (Drug)
SPMC1D
Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy
干预措施: Natrium picosulfate / Magnesium citrate (Drug)
SPMC2D
Natrium picosulfate/ Magnesium citrate split dose
干预措施: Natrium picosulfate / Magnesium citrate (Drug)
PEGA1D
Polyethylene glycol / Ascorbic acid single dose day before colonoscopy
干预措施: Polyethylene glycol / Ascorbic acid (Drug)
PEGA2D
Polyethylene glycol / Ascorbic acid split dose
干预措施: Polyethylene glycol / Ascorbic acid (Drug)
结局指标
主要结局
Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
时间窗: One day
Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)
次要结局
- Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)(One day)
研究者
Vladimir Kojecky, MD, Ph.D.
MUDr.
Tomas Bata Hospital, Czech Republic