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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04958525

Collaborator

(none)

Enrollment

Location

28.9

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Basal Ganglia Hemorrhage	Procedure: Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal Procedure: Small bone window craniotomy for hematoma removal under microscope

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Endoscopic Surgery Group After a full evaluation of the patient's condition, the informed consent was signed to perform keyhole neuroendoscopic ultrasound-guided hematoma removal for the patient.	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.
Microsurgery group After a full evaluation of the patient's condition, the informed consent was signed to perform small bone window craniotomy for hematoma removal under microscope for the patient.	Procedure: 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.

Arm

Intervention/Treatment

Endoscopic Surgery Group

After a full evaluation of the patient's condition, the informed consent was signed to perform keyhole neuroendoscopic ultrasound-guided hematoma removal for the patient.

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.

Microsurgery group

After a full evaluation of the patient's condition, the informed consent was signed to perform small bone window craniotomy for hematoma removal under microscope for the patient.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Hemorrhage clearance evaluation [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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