Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
试验速览
- 阶段
- 4 期
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- the Boston Bowel Preparation Scale
研究概览
简要总结
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients aged 18-75 years
- •Referred for routine diagnostic colonoscopy
- •Patients who have signed inform consent form
排除标准
- •pregnancy or breastfeeding
- •allergy to purgatives
- •suspected intestinal obstruction, stricture, or perforation
- •hemodynamic instability
- •impaired swallowing reflex or mental status
- •severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
- •history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
- •participation declined.
研究组 & 干预措施
4L Polyethylene Glycol
4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.
干预措施: 4L Polyethylene Glycol (Drug)
3L Polyethylene Glycol
3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.
干预措施: 3L Polyethylene Glycol (Drug)
结局指标
主要结局
the Boston Bowel Preparation Scale
时间窗: 2 days
The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
次要结局
- The mean number of incremental adenomas(2 days)
- Polyp detection rate(2 days)
- Adenoma detection rate(2 days)
研究者
Zhaoshen Li
Director of Gastroenterology Dept and Digestive Endoscopy Center
Changhai Hospital