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Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03447327
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Information provided by (Responsible Party):
Hosni Salama, Zagazig University

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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Procedure: single burr hole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Actual Study Start Date : March 5, 2014
Actual Primary Completion Date : February 28, 2015
Actual Study Completion Date : August 28, 2015

Arm Intervention/treatment
operated group
patients undergoing surgery for chronic subdural hematoma by single burr hole under local anaesthesia
Procedure: single burr hole
patients with CSDH operated by single burr hole craniostomy under local anaesthesia

Primary Outcome Measures :
  1. Glasgow Outcome Scale [ Time Frame: 6 months postoperative ]
    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

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:chronic subdural hematoma above 19 years old -

Exclusion Criteria:age below 19 years acute subduralhematoma uncoperative patients

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Responsible Party: Hosni Salama, Assistant professor, Zagazig University Identifier: NCT03447327     History of Changes
Other Study ID Numbers: ZU-IRB#3893-03-03-2014
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Central Nervous System Depressants
Physiological Effects of Drugs