Clinical trial NCT04958525: Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage by Transfrontal Keyhole Neuroendoscopy
Official title: A Controlled Observational Study on Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage by Transfrontal Keyhole Neuroendoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basal Ganglia Hemorrhage
Keywords: Hypertensive basal ganglia hemorrhage
Transfrontal keyhole neuroendoscopic technique
Ultrasonic positioning
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients from Peking University Third Hospital

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemorrhage clearance evaluation
timeFrame: 3 months after surgery was done
measure: Prognosis of Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage
timeFrame: 3 months after surgery was done
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Haidian
Study officials:
affiliation: Peking University Third Hospital
name: Liu Bin
role: PRINCIPAL_INVESTIGATOR
References: