Back to resultsOutcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Primary Purpose
Chronic Subdural Hematoma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single burr hole
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma
Eligibility Criteria
Inclusion Criteria:chronic subdural hematoma above 19 years old -
Exclusion Criteria:age below 19 years acute subduralhematoma uncoperative patients
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
operated group
Arm Description
patients undergoing surgery for chronic subdural hematoma by single burr hole under local anaesthesia
Outcomes
Primary Outcome Measures
Glasgow Outcome Scale
The Glasgow Outcome Scale was used as measuremabilityent for neurological oucome after surgery.The patients were classified as as dead, persistant vegetative state, severe disability, moderate disability, and mild dis
Secondary Outcome Measures
Full Information
NCT ID
NCT03447327
First Posted
February 20, 2018
Last Updated
February 25, 2018
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT03447327
Brief Title
Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Official Title
Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 2014 (Actual)
Primary Completion Date
February 28, 2015 (Actual)
Study Completion Date
August 28, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the work: Is to evaluate the prognosis of single burr hole under local anesthesia in management of CSDH according to clinical picture, risk factors, and age.
Detailed Description
Patients and methods: We studied 67 consecutive patients with CSDH operated by single burr hole craniostomy under local anaesthesia from Mars, 2014 to February, 2015 in Zagazig University Hospitals according to the aetiology, clinical picture, risk factors, and complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
operated group
Arm Type
Other
Arm Description
patients undergoing surgery for chronic subdural hematoma by single burr hole under local anaesthesia
Intervention Type
Procedure
Intervention Name(s)
single burr hole
Intervention Description
patients with CSDH operated by single burr hole craniostomy under local anaesthesia
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale
Description
The Glasgow Outcome Scale was used as measuremabilityent for neurological oucome after surgery.The patients were classified as as dead, persistant vegetative state, severe disability, moderate disability, and mild dis
Time Frame
6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:chronic subdural hematoma above 19 years old -
Exclusion Criteria:age below 19 years acute subduralhematoma uncoperative patients
-
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
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