Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 940
- 试验地点
- 3
- 主要终点
- Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
研究概览
简要总结
Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.
Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing colonoscopy;
- •Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):
- •Constipation
- •Parkinson's disease
- •History of stroke or spine cord injure
- •Prior history of inadequate bowel preparation
- •Use of tricyclic antidepressant or narcotics
排除标准
- •History of colorectal resection;
- •Suspected colonic stricture or perforation;
- •Incomplete or complete bowel obstruction;
- •Use of prokinetic agents or purgatives within 7 days;
- •Toxic colitis or megacolon;
- •Pregnancy or lactation;
- •Unable to give informed consent;
- •Haemodynamically unstable.
研究组 & 干预措施
Single dose of 2L PEG
2 L of PEG solution was used on the day of colonoscopy.
干预措施: Single dose of 2L PEG (Drug)
Split-dose of 4L PEG
Split-dose of 4l PEG was used before and on the day of colonoscopy
干预措施: Split dose of 4L PEG (Drug)
结局指标
主要结局
Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
时间窗: 1 year
The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.
次要结局
- Polyp detection rate(1 year)
- Cecal intubation time(1 year)
- Withdrawal time(1 year)
- Rate of adverse events(1 year)
- Cecal intubation rate(1 year)
- Willingness to repeat bowel preparation(1 year)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China