Oral Lactulose is Not Inferior to The Standard Bowel Preparation Regimen for Bowel Preparation Prior Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 主要终点
- Bowel preparation
研究概览
简要总结
Adequate quality of bowel preparation(BP) is essential 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 caused lower compliance to the regime and increased cost.
Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-80 patients with intact colon and rectum
排除标准
- •prior finding of severe colorectal stricture
- •without the requirement of reaching cecum
- •suspected colonic stricture or perforation
- •use of prokinetic agents or purgatives within 7 days
- •toxic colitis or megacolon
- •pregnant women
- •hemodynamically unstable
- •patients who cannot give informed consent
研究组 & 干预措施
Experiment cohort
4-6 hours before colonoscopy, patients in experiment cohort began to drink the first 150ml lactulose and half hour later, drink other 150ml lactulose dissolved in 1.5 L of water at a rate of 250ml every 15 minutes.
干预措施: Lactulose (Drug)
Control cohort
The participants in control cohort began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
干预措施: Polyethylene Glycol (PEG) (Drug)
结局指标
主要结局
Bowel preparation
时间窗: 2 hours
Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
次要结局
- Adverse events(2 hours)
- Willingness to repeat bowel preparation (BP)(2 hours)
- Adenoma detection rate(2 hours)
- Insertion time(2 hours)
- Withdrawal time(2 hours)
- Cecal intubation rate(2 hours)
研究者
ZhangXiaofeng
Director of Department of Gastroenterology
First People's Hospital of Hangzhou