Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff During Percutaneous or Conventional Surgery of Hallux Valgus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Irradiation collected at the end of the operation on the surgeon's active dosimeter
研究概览
简要总结
To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.
详细描述
Prospective, open, comparative, non-randomized, non-interventional, single-center study, focusing on two surgical strategies. Patients will be managed in accordance with current practice, the choice of surgical strategy being left to the discretion of the investigators.
Patients will be informed of the study during a preoperative visit. The data concerning them will be collected on the day of the surgery. No follow-up over time is necessary.
Passive "ring" and "cornea" dosimeters will be worn by healthcare professionals during procedures for patients included in the study. Their data will be collected each month and at the end of the study, and reported secondarily to the number of operations. Several surgeons, dressers and operating assistants will participate in the operations, their data will be aggregated taking into account their function and not individuals.
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
- •Patient undergoing percutaneous or conventional hallux valgus surgery;
- •Patient capable of understanding the information related to the study, of reading the information leaflet and having expressed his non-opposition to participating in the study.
排除标准
- •Pregnant or breastfeeding woman;
- •Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
结局指标
主要结局
Irradiation collected at the end of the operation on the surgeon's active dosimeter
时间窗: during the time of the surgery
Measure of irradiation in mGy.cm² by a dosimeter
次要结局
- Irradiation collected at the end of the operation on the patient's and operating team's(during the time of the surgery)
- Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional(3 months)