The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,200
- 试验地点
- 1
- 主要终点
- Change in screening centre adenoma detection rate before and after intervention
研究概览
简要总结
Routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy. The purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy. The study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy quality measures will be monitored through a dedicated joint database. Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group. Screening centres assigned to the video recording group will receive videorecorders and DVDs and will be asked to video record all screening colonoscopies (only withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the colonoscopy quality measures will again be monitored through a dedicated joint database. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening centres participating in the Polish Colonoscopy Screening Platform (PCSP) between 2012 and 2013, in which no routine video recording of screening colonoscopies is performed
- •Screening centres which will sign informed consent
排除标准
- 未提供
结局指标
主要结局
Change in screening centre adenoma detection rate before and after intervention
时间窗: From the time of randomization up to 10 months (the end of screening program annual edition)
Proportion of patients with at least one adenoma identified (measured in screening program database).
次要结局
- Reported and audited ceacal intubation rates(From the time of randomization up to 10 months (the end of screening program annual edition))
- Rates of painful colonoscopy(From the time of randomization up to 10 months (the end of screening program annual edition))
- Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size(From the time of randomization up to 10 months (the end of screening program annual edition))