Effect of Lactulose and/ or Polyethylene Glycol Solution for Bowel Preparation in Colonscopy: a Multi-center Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The quality of bowel preparation
研究概览
简要总结
Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication. However, the taste is poor, and patients need to drink a lot of liquids to obtain adequate visualization of the mucosal surface. In fact, no laxative has all the characteristics of an ideal medication. Lactulose is an osmotic laxative which widely used in cirrhosis and constipation patients, and could inhibit bacterial in the colon to increase colon cleanliness and prolong the effect time of PEG. Previous study demonstrate PEG combined with lactulose has a significant improvement in the quality of bowel preparation compared with PEG alone. The present study aim to assess the efficacy of lactulose with or without PEG in bowel preparation to improve mucosal visualization, reduced volume of fluid consumed, and preparation intolerance.
详细描述
This study will conduct in 5 clinical central. 1000 participants who were scheduled for colonoscopy age between 18 and 80 years were enrolled in the study. Exclusion criteria were patients with uncontrolled acute or recurrent chronic intestinal infections, with active gastrointestinal bleeding or gastrointestinal stricture or intestinal obstruction, with severity coronary heart disease or heart failure or renal failure and liver failure or severe electrolyte metabolism disorder, with pregnant or lactating or metal diseases or refuse to colonoscopy examination. Central stratification and block randomization is achieved via a computer-generated random-sequence table by using R software. The participants will be assigned into one of four groups at a ratio of 1 : 1, and received a single 3 L dose of either PEG or 200ml dose of lactulose, 100ml lactulose combined with 1L PEG, 100ml lactulose combined with 2L PEG. The following parameters were then obtained: time of the first defecation, defecation frequency, the overall drink liquid volume, the taste of the preparation, the tolerance evaluation, the cleansing quality of the bowel preparations and adverse reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (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
- •Participants who were scheduled for colonoscopy age between 18 and 80 years
排除标准
- •uncontrolled acute or recurrent chronic intestinal infections
- •active gastrointestinal bleeding, gastrointestinal stricture, intestinal obstruction
- •severe electrolyte metabolism disorder, severe coronary heart disease, heart failure, renal failure or liver failure
- •pregnant, lactating, have metal diseases or refuse to colonoscopy examination
研究组 & 干预措施
3 L Polyethylene glycol solution group
The participants were instructed to consume 3000 mL of PEG solution
干预措施: 3 L Polyethylene glycol solution (Drug)
100 ml lactulose combined with 1 L PEG group
the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution
干预措施: 100 ml lactulose combined with 1 L PEG (Drug)
100 ml lactulose combined with 2 L PEG group
the participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution
干预措施: 100 ml lactulose combined with 2 L PEG (Drug)
200 ml lactulose group
the participants were instructed to consume 200 ml lactulose
干预措施: 200 ml lactulose (Drug)
结局指标
主要结局
The quality of bowel preparation
时间窗: up to 12 months
to assess the quality of bowel preparation by using Boston Bowel Preparation Scale. The minimum score value is 0，and the maximum value is 9. A higher score means a better outcome. Bowel cleansing was scored by the endoscopist performing the colonoscopy in the single-blind method.
The preparation intolerance
时间窗: up to 12 months
to assess the preparation intolerance including the palatability of the bowel-cleansing agents, the general satisfaction with the bowel preparation, the willingness to perform another colonoscopy by using case report questionnaire. Moreover, the ratio of drink all preparation fluids and the specific amount of bowel preparation fluid are documented.
次要结局
- The colorectal diseases detection rate(up to 12 months)
- The adverse events(up to 12 months)
研究者
Lin Cai
Principal Investigator
Sichuan University