Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage by Transfrontal Keyhole Neuroendoscopy

Basal Ganglia Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958525
• Other study ID #: M2020543
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Liu Bin
• Phone: 13671027688
• Email: liubin301[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Basal Ganglia Hemorrhage
• Ganglion Cysts
• Hemorrhage

Intervention

Procedure:
• Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal
Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal in basal ganglia region:According to the brain CT scan and reconstruct the operation plan, choose a side by 2 cm before the coronal suture line 4 cm and 3 cm center longitudinal incision formation of 2 cm bone drilling the hole, ultrasonic measurement and the size of hematoma puncture depth, and guide the puncture direction, the transparent channel under endoscopic direct placement hematoma backend, after entering the hematoma cavity, under the neural endoscopic removal of hematoma,Wash the hematoma cavity with warm salt water.Bipolar electrocoagulation hemostasis for active bleeding.An indwelling drainage tube was placed in the hematoma cavity, and ultrasonography determined that the hematoma was cleared satisfily without active bleeding.
• Small bone window craniotomy for hematoma removal under microscope
Small bone window craniotomy for hematoma removal under microscope:Small bone window craniotomy in frontotemporal region, no blood vessels and non-functional areas of the hematoma nearest to the cortex was cut open, the hematoma was removed under the microscope and the cavity of the hematoma was washed with warm saline, and bipolar electrocoagulation hemostasis was performed for active bleeding.An indwelling drainage tube was placed in the hematoma cavity and the operation was completed without active bleeding.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Peking	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemorrhage clearance evaluation	Preoperative and postoperative hematoma volume and hematoma clearance rate were evaluated by cerebral fibrous tract imaging	3 months after surgery was done
Primary	Prognosis of Minimally Invasive Treatment of Hypertensive Basal Ganglia Hemorrhage	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.	3 months after surgery was done