A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 3
- 主要终点
- bowel cleansing
研究概览
简要总结
This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (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
- •all patients > 18 years of age undergoing elective colonoscopy on an outpatient basis
排除标准
- •refusal to sign informed consent
- •pregnancy
- •advance kidney, liver or heart disease
- •suspicion of malignant / benign stenosis of the digestive tract
研究组 & 干预措施
Standard approach
patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic:
- 4L split polyethylene glycol solution
- split magnesium citrate/sodium picosulphate preparation regimen
干预措施: Standard approach (Drug)
Individualized approach
patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level)
干预措施: Individualized approach (Drug)
结局指标
主要结局
bowel cleansing
时间窗: 24 hours
bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)
次要结局
- patient comfort level during bowel cleansing(24 hours)
研究者
dr. Theodor Alexandru Voiosu
MD, gastroenterology resident
Clinical Hospital Colentina