IMPlementing Split Regimen OVEr Single Dose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,267
- 主要终点
- Number of participants adopting a split-dose regimen in Cycle1
研究概览
简要总结
The split-dose regimen (SpD) has demonstrated its superiority over the day-before regimen (DB) in determining a better colon cleansing and is considered the standard bowel preparation for colonoscopies by the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. However its application is still suboptimal due to concerns about patient acceptability, fluid aspiration due to residual gastric contents and challenging viability for early morning colonoscopies. Barriers precluding the prescription of SpD have been explored in few studies mainly in the setting of auditing of current practice, while corrective measure aiming at changing this practice have been prospectively tested in very few, small and selected, cohorts. The present study has the aim of surveying split-dose regimen adoption rate among several endoscopic centres before and after an improvement phase following a plan-do-study-act approach, in order to analyse and correct factors preventing its adoption. A multivariate analysis was planned in order to use collected data to infer factors favouring and limiting split-dose regimen adoption.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Subjects undergoing colonoscopy with full bowel cleansing
排除标准
- •Incapacity to give informed consent
- •Partial colonoscopy
研究组 & 干预措施
Cycle1
Patients undergoing colonoscopy with full bowel cleansing before the improvement phase
干预措施: Colonoscopy (Procedure)
Cycle1
Patients undergoing colonoscopy with full bowel cleansing before the improvement phase
干预措施: Bowel cleansing regimen (Drug)
Cycle2
Patients undergoing colonoscopy with full bowel cleansing after the improvement phase
干预措施: Colonoscopy (Procedure)
Cycle2
Patients undergoing colonoscopy with full bowel cleansing after the improvement phase
干预措施: Bowel cleansing regimen (Drug)
结局指标
主要结局
Number of participants adopting a split-dose regimen in Cycle1
时间窗: 6 months
Number of participants adopting a split-dose regimen in Cycle2
时间窗: 3 months
Change from Cycle1 in the proportion of patients adopting a split-dose regimen during Cycle2 after an improvement phase
时间窗: 9 months (Cycle1 = 6 months + Cycle2 = 3 months, separated by a 21-month improvement phase)
次要结局
未报告次要终点
研究者
Emilio Di Giulio
Head of Endoscopy Unit
S. Andrea Hospital
