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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04958525
Other study ID # M2020543
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04839770 - MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage N/A