Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Improved bowel preparation
研究概览
简要总结
Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.
The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •previous IBP
- •concurrent medical conditions (e.g. diabetes, constipation)
- •medications (e.g. opioids and tricyclic antidepressants)
排除标准
- •previous colonic resection
- •patients with IBD
- •active CRC
- •chronic kidney disease at any stage
- •congestive heart failure at any stage
- •liver cirrhosis
研究组 & 干预措施
Interventional arm (group A)
Patients with risk factors for IBP who will receive "intensified" bowel preparation
干预措施: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure (Drug)
Control arm (group B)
Patients with risk factors for IBP who will receive standard bowel preparation
干预措施: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure (Drug)
Control arm (group c)
Patients without risk factors for IPB who will receive standard bowel preparation
干预措施: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure (Drug)
结局指标
主要结局
Improved bowel preparation
时间窗: Index colonoscopy
Boston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment.
次要结局
未报告次要终点
研究者
Amir Klein MD
Principal Investigator
Rambam Health Care Campus