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临床试验/NCT04961424
NCT04961424已完成不适用

Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Cerebrospinal fluid leakage

研究概览

简要总结

This is a retrospective, observational single-center study. The studies is to investigate the incidence of posterior epidural spinal hematoma(PSEH) and recognize the risk factors for it in a cohort of patients undergoing posterior thoracic surgery in isolation.

详细描述

The study enrolled patients from January 2010 to December 2019, patients who developed PSEH after posterior thoracic surgery and underwent the hematoma evacuation. For each PSEH patients, 2 or 3 controls who did not develop the PSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period were collected. The preoperative and intraoperative factors, blood pressure related factors and radiographic parameters were collected to identify possible risk factors by comparing between two groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects satisfying the following criteria will be considered eligible for enrollment in this study:
  • Patient is ≥ 18 years and < 80 years of age;
  • Patient who received thoracic decompression surgery via posterior approach
  • Patient who diagnosed as symptomatic spinal epidural haematoma and received revision surgery.

排除标准

  • Thoracic spinal stenosis caused by trauma, tumor, infectious, deformity and other disease;
  • Symptomatic spinal epidural haematoma happened at cervicothoracic and thoracolumbar junction;
  • Initial surgeries were performed at other hospital;
  • Incomplete clinical data.

结局指标

主要结局

Cerebrospinal fluid leakage

时间窗: 6 months

Cerebrospinal fluid leakage provides internal pressure for the dura and its own contents, and a small haematoma does not easily induce symptoms. It is the author's hypothesis that if cerebrospinal fluid leakage occurs intraoperatively, internal pressure loss, even in a small hematoma, can cause compression. Therefore, cerebrospinal fluid leakage are considered as a risk factor for symptomatic spinal epidural hematoma

High occupying ratio of cross-sectional area

时间窗: 6 months

Severe compression on spinal epidural venous plexus lead to poor elasticity of the vessel wall and impedance of blood flow. As a result, dilatation of the spinal epidural venous plexus are more often in symptomatic spinal epidural haematoma patients, contributing to the development of haematoma. Therefore, high occupying ratio of cross-sectional area is considered as a risk factors for symptomatic spinal epidural hematoma.

Large local kyphosis angle

时间窗: 6 months

The local kyphosis angle was determined by the measurement of the Cobb angle. Large local kyphosis angle creates a narrow space between the paravertebral muscles and spinal cord, especially in muscles with edema after surgery. Large local kyphosis angle is considered as a risk factor for symptomatic spinal epidural hematoma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Weishi

Director of the orthopaedic department

Peking University Third Hospital

研究点 (1)

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