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

July 8, 2021 updated by: Peking University Third Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Wu Chao
  • Phone Number: 15650779903

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemorrhage clearance evaluation
Time Frame: 3 months after surgery was done
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
Time Frame: 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.
3 months after surgery was done

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liu Bin, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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