Interventional Reference Levels (IRL) in Digestive Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.
研究概览
简要总结
Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.
Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.
Secondary objective(s) :
- Application of regulatory texts
- Assessment of patient radiation protection
- Radiation protection assessment for workers
详细描述
Prospective data collection using an e-CRF available via Easymedstat. Data completed during the endoscopy procedure Completion of a questionnaire by the practitioner who performed the procedure afterwards, including the scopy doses used during the procedure, the type of scopy, the type of intention-to-treat
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who have received an X-ray dose during an endoscopic procedure
排除标准
- •No X-rays produced
- •Medical indication not in favour of the scopy procedure in view of the benefit/risk balance
结局指标
主要结局
To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.
时间窗: From enrollment to the end of data collection at 3 months
IRL is the mean for all endoscopic procedure using scopy, it is calculated by multiplying the PDS in Gy.cm2 with the time during witch the patient as been expose to Xrays during the procedure
次要结局
- Application of regulatory texts(From enrollment to the end of data collection at 3 months)
- Assessment of patient radiation protection(From enrollment to the end of data collection at 3 months)
- Radiation protection assessment for workers(From enrollment to the end of data collection at 3 months)