A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- the index of preparation quality for the whole colon
研究概览
简要总结
This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.
详细描述
Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.
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
- •men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
- •provided written informed consent
排除标准
- •lack of written informed consent or inability to provide informed consent or refusal to consent to the study
- •pregnancy and breast feeding
- •known allergy to PEG or bisakodyl
- •presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
- •colonoscopy performed under conscious sedation
研究组 & 干预措施
split-dose polyethylene glycol solution
first dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy
干预措施: individual preparation for colonoscopy (Other)
Individual preparation for colonoscopy
干预措施: individual preparation for colonoscopy (Other)
结局指标
主要结局
the index of preparation quality for the whole colon
时间窗: 24 hours
the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale
次要结局
- compliance safety(24 hours)