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

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

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

Study Overview

• Status: Recruiting
• Conditions: Basal Ganglia Hemorrhage
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 52

Contacts and Locations

• Study Contact: Name: Wu Chao; Phone Number: 15650779903

Study Locations

• China
  • Haidian
    • Peking, Haidian, China, 100191
      • Recruiting
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients from Peking University Third Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Liu Bin, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (ACTUAL): July 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Hypertensive basal ganglia hemorrhage; Transfrontal keyhole neuroendoscopic technique; Ultrasonic positioning
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Cysts; Connective Tissue Diseases; Basal Ganglia Diseases; Mucinoses; Intracranial Hemorrhages; Basal Ganglia Cerebrovascular Disease; Cerebral Hemorrhage; Hemorrhage; Ganglion Cysts; Synovial Cyst; Basal Ganglia Hemorrhage
• Other Study ID Numbers: M2020543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No