Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 429
- 试验地点
- 1
- 主要终点
- adequate bowel preparation rates between 2 groups.
研究概览
简要总结
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.
详细描述
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •patients aged 18 or older
- •patients undergoing colonoscopy
排除标准
- •patients with a history of colorectal surgery
- •patients with severe colonic stricture or obstructing tumor
- •patients with dysphagia
- •patients with compromised swallowing reflex or mental status
- •patients with significant gastroparesis or gastric outlet obstruction
- •patients with known or suspected bowel obstruction or perforation
- •patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- •patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- •patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •patients with inflammatory bowel disease or megacolon
- •patients with dehydration
- •patients with dehydration
- •patients with pregnancy or lactation
- •patients hemodynamically unstable
- •patients unable to give informed consent
研究组 & 干预措施
Group A: standard group
Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
干预措施: Polyethylene Glycol (PEG) (Drug)
Group B: tailored group
Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).
Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.
干预措施: Polyethylene Glycol (PEG) (Drug)
结局指标
主要结局
adequate bowel preparation rates between 2 groups.
时间窗: 4 months
adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
次要结局
未报告次要终点
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University