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临床试验/NCT04958525
NCT04958525Unknown不适用

A Controlled Observational Study on Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage by Transfrontal Keyhole Neuroendoscopy

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
1
主要终点
Hemorrhage clearance evaluation

研究概览

简要总结

To compare the prognosis of patients with hypertensive intracerebral hemorrhage treated by two different surgical methods, and to clarify the therapeutic effect of minimally invasive surgery, so as to find a better surgical method that can reduce surgical trauma and mortality and improve the prognosis of patients

详细描述

In this study, a cohort observation method was adopted to observe a total of 52 patients who underwent two surgical procedures, namely, removal of hematoma in basal ganglo-region by keyhole neuroendoscopy under frontal ultrasound guidance and removal of hematoma by craniotomy microsurgery. They were divided into the endoscopic surgery group and the microsurgery group. In the endoscopic surgery group, 26 patients underwent removal of hematoma in basal ganglo-region by keyhole neuroendoscopy under frontal ultrasound guidance.In the microsurgery group, 26 cases were treated with craniotomy microsurgery for hematoma removal. The clearance rate of surgical hematoma, surgical safety, GCS score, GOS score, nerve fiber injury and postoperative complications were observed in the two groups 1 week, 1 month and 3 months after surgery.To observe and analyze whether endoscopic surgery group has advantages in improving hematoma clearance rate and efficacy

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
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CT scan was used to diagnose cerebral hemorrhage in basal ganglia region. The amount of bleeding was 30-50ml, and no cerebral hernia was formed.
  • Age between 30 and 70
  • The onset is longer than 24 hours and less than 72 hours.
  • Informed consent of the patient and/or their relative.

排除标准

  • Brain injury, hemorrhage caused by intracranial aneurysm or cerebral arteriovenous malformation.
  • Coagulation dysfunction
  • Insufficiency of vital organs of heart, liver, kidney or lung
  • Previous history of stroke with functional loss
  • Intracranial or systemic infection
  • Poor blood pressure control

结局指标

主要结局

Hemorrhage clearance evaluation

时间窗: 3 months after surgery was done

Preoperative and postoperative hematoma volume and hematoma clearance rate were evaluated by cerebral fibrous tract imaging

Prognosis of Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage

时间窗: 3 months after surgery was done

Glasgow coma score (GCS) score, GOS score, 1 month postoperative mortality, and 7 days postoperative complications were evaluated: gastrointestinal stress ulcer bleeding, intracranial infection.Mortality and Glasgow and GOS scores at 30 days and 3 months after surgery were evaluated by telephone interviews or inpatient records.

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 (1)

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