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

NCT04958525 | Unknown

• 1 other identifier: M2020543
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Basal Ganglia Hemorrhage

Keywords

Hypertensive basal ganglia hemorrhage; Transfrontal keyhole neuroendoscopic technique; Ultrasonic positioning

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal PROCEDURE

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.

Endoscopic Surgery Group

Small bone window craniotomy for hematoma removal under microscope PROCEDURE

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.

Microsurgery group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients from Peking University Third Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Haidian, 100191, China

RECRUITING

MeSH Terms

Conditions

Basal Ganglia Hemorrhage

Condition Hierarchy (Ancestors)

Basal Ganglia Cerebrovascular Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Cerebral Hemorrhage; Intracranial Hemorrhages; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liu Bin

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Bin

CONTACT

13671027688; liubin301@163.com

Wu Chao

CONTACT

15650779903

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 12, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 12, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)