Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- concordance of the operating site after radiological and ultrasound guidance
研究概览
简要总结
The identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient.
The use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. However, it is commonly used for other types of scouting (especially anesthetics). Thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . Methodological developments also validate the feasibility of the ultrasound approach.
The double benefit of an ultrasound identification is firstly a lack of exposure to X-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography.
The main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Major patients
- •Patients who gave their consent
- •Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation
排除标准
- •Pregnant or lactating women according to article L1121-5 of the CSP.
- •Vulnerable persons according to article L1121-6 of the CSP.
- •Major persons placed under guardianship or curatorship
研究组 & 干预措施
Single arm study
Ultrasound plus radiographic guidance
干预措施: Ultrasound guidance in addition to radiographic guidance (Procedure)
结局指标
主要结局
concordance of the operating site after radiological and ultrasound guidance
时间窗: day 1
ok / not ok
次要结局
- number of shots made and preventable(day 0)
- preventable radiation dose(day 0)
- exam costs (based on national cost scale)(day 0)
