Outcome of Single Burr Hole Under Local Anaesthesia in th... | NCT03447327

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

NCT03447327

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Chronic Subdural Hematoma

Interventions

single burr hole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2014Actual

Primary Completion Date

Feb 28, 2015Actual

Completion Date

Aug 28, 2015Actual

First Submitted Date

Feb 20, 2018

First Submission Date that Met QC Criteria

Feb 25, 2018

First Posted Date

Feb 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2018

Last Update Posted Date

Feb 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
operated group	Other	patients undergoing surgery for chronic subdural hematoma by single burr hole under local anaesthesia	Procedure: single burr hole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single burr hole	Procedure	patients with CSDH operated by single burr hole craniostomy under local anaesthesia	operated group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:chronic subdural hematoma above 19 years old -

Exclusion Criteria:age below 19 years acute subduralhematoma uncoperative patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020200	Hematoma, Subdural, Chronic

Ancestor Terms

ID	Term
D006408	Hematoma, Subdural
D020198	Intracranial Hemorrhage, Traumatic
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014207	Trephining

Ancestor Terms

ID	Term
D003399	Craniotomy
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided