跳至主要内容
临床试验/NCT04124627
NCT04124627Unknown不适用

Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

发起方
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
申办方类型
Network
责任方
Sponsor

研究点 (2)

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