Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification：a Multicenter, Endoscopist-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,028
- 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 evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.
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 and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone 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)
盲法说明
The allocation assignment of patients was performed by a designated technician at each center based on a computer-generated random sequence. The designated technician was not involved in the colonoscopy procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults undergoing colonoscopy.
排除标准
- •1.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);
- •2.Patients with galactosemia;
- •hypersensitivity to any of the ingredients;
- •4.Pregnancy or lactation;
- •5.Use of lactulose,prokinetic agents or purgatives within 7 days;
- •6.Unwilling to sign informed consent.
研究组 & 干预措施
PEG (low-risk patients and high-risk patients)
The dosing regimen of low-risk patients and high-risk patients will only be PEG.
干预措施: PEG (Drug)
PEG+lactulose (low-risk patients and high-risk patients)
The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose.
干预措施: PEG+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
- Cecal intubation time(during colonoscopy)
- Rate of adverse events(2 days)
- Adenoma Detection Rate(2 days)
- Cecal intubation rate(during colonoscopy)
- Withdrawal time(during colonoscopy)
- defecation frequency(2 days)
- Willingness to repeat bowel preparation(2 days)
研究者
ChenMingkai
Chief physician of Department of Gastroenterology I
Renmin Hospital of Wuhan University