Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation#a Single-center,Endoscopist-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale
研究概览
简要总结
The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population.
详细描述
The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors.This is a single-center ,endoscopist-blinded study to compare the efficacy of CSP combined with lactulose and PEG combined with lactulose in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.
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
- Single (Investigator)
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
- •Adults undergoing colonoscopy who have at least one risk factor: age>70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics.
排除标准
- •presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
- •Patients with galactosemia;
- •hypersensitivity to any of the ingredients;
- •Pregnancy or lactation;
- •Use of lactulose,prokinetic agents or purgatives within 7 days;
- •Unwilling to sign informed consent.
研究组 & 干预措施
the control group
The dosing regimen of high-risk patients will be PEG combined with lactulose.
干预措施: PEG+lactulose (Drug)
CSP+lactulose group
The dosing regimen of high-risk patients will be CSP combined with lactulose.
干预措施: CSP＋lactulose (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale
时间窗: during colonoscopy
Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is 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. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation.
次要结局
- Adenoma Detection Rate(2 days)
- Rate of adverse events(2 days)
- Cecal intubation rate(during colonoscopy)
- Polyp Detection Rate(2 days)
- defecation frequency(2 days)
- Cecal intubation time(during colonoscopy)
- Withdrawal time(during colonoscopy)
- patient satisfaction Assessment(2 days)
研究者
ChenMingkai
Professor
Renmin Hospital of Wuhan University