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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: single burr hole

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:chronic subdural hematoma above 19 years old -

Exclusion Criteria:age below 19 years acute subduralhematoma uncoperative patients

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2014
• Primary Completion (Actual): February 28, 2015
• Study Completion (Actual): August 28, 2015

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: ZU-IRB#3893-03-03-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No