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

• Conditions: Basal Ganglia Hemorrhage
• Interventions: Procedure: Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal; Procedure: Small bone window craniotomy for hematoma removal under microscope

• Registration Number: NCT04958525
• Lead Sponsor: 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

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Primary Completion: 2022-06-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic Surgery Group	Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal	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.
Microsurgery group	Small bone window craniotomy for hematoma removal under microscope	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Peking, Haidian, China