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临床试验/NCT03581175
NCT03581175已完成不适用

IMPlementing Split Regimen OVEr Single Dose

S. Andrea Hospital0 个研究点目标入组 8,267 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

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

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

发起方
S. Andrea Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emilio Di Giulio

Head of Endoscopy Unit

S. Andrea Hospital

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