跳至主要内容
临床试验/NCT04465305
NCT04465305Unknown不适用

A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts

Peking University Third Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
2
主要终点
recurrent rate of tarlov cysts

研究概览

简要总结

The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst

详细描述

In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic nerve root cysts diagnosed by MRI
  • Intact cyst capsule, no defect of sacral canal lamina
  • No other diseases of nervous system, pelvic floor and important organs
  • Agree inclusion

排除标准

  • a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -

结局指标

主要结局

recurrent rate of tarlov cysts

时间窗: 1 year

patents who recurrent postoperation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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