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CompletedNCT03447327Updated Feb 27, 2018

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

An interventional study of single burr hole in Chronic Subdural Hematoma, sponsored by Zagazig University. Completed. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Mar 2014, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Not applicable
Ages
19 Years to 90 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Chronic Subdural Hematoma
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In context

Hematoma, Subdural, Chronic

112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.

This study's enrollment of 67 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.

Browse Hematoma, Subdural, Chronic studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
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

-

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Other
    operated group

    patients undergoing surgery for chronic subdural hematoma by single burr hole under local anaesthesia

    Procedure: single burr hole

Interventions

  • Proceduresingle burr hole

    patients with CSDH operated by single burr hole craniostomy under local anaesthesia

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2014 to primary completion in Feb 2015, 11 months.

Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2018
First posted
Feb 27, 2018
StartActual
Mar 5, 2014
Primary completionActual
Feb 28, 2015
CompletionActual
Aug 28, 2015
Last update
Feb 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03447327
Lead sponsor
Zagazig University
Responsible party
Hosni Salama (Assistant professor, Zagazig University) — Principal investigator
First posted
Feb 27, 2018
Start date
Mar 5, 2014
Primary completion
Feb 28, 2015
Completion
Aug 28, 2015
Last update
Feb 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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