Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000552280
Ethics application status
Approved
Date submitted
18/02/2018
Date registered
13/04/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
How deep is epidural space? Correlation between MRI, USG and Actual Depth: A Prospective Observational Study
Scientific title
How deep is epidural space? Correlation between MRI, USG and Actual Depth: A Prospective Observational Study of patients undergoing lumbar spine surgery
Secondary ID [1] 294030 0
none
Universal Trial Number (UTN)
U1111-1209-2776
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ultrasonographic imaging 306565 0
lumbal herniated nucleus pulposus surgery 306657 0
magnetic resonance imaging 306658 0
Condition category
Condition code
Musculoskeletal 305658 305658 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The depth of the epidural space will be measured using ultrasound with a convex ultrasound probe from skin to ligamentum flavum and dura and also the depth of epidural space will be measured from the magnetic resonance imaging of the patient that was obtained before the operation which is a regular process in our institution. The actual depth of epidural space will be measured with a sterile disposable tape measure by the surgeon operating the patient for lumbal herniated nucleus pulposus when he/she reaches the level of dura during surgical exploration which lasts for 2 hours .
Intervention code [1] 300301 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304766 0
measurement of epidural depth will be assessed with ultrasound using the 2-5 Mhz curved array probe in transverse plane ( transverse plane is the horizontal plane of the body where ultrasound beams see the antero-posterior structures in horizontal section of the body,) in patients undergoing lumbar herniated nucleus pulposus surgery.
Timepoint [1] 304766 0
lumbar epidural space depth will be measured by ultrasound before the operation afterwhen the patient is in the operation room and monitorized.
Primary outcome [2] 305369 0
measurement of epidural depth will be assessed with ultrasound using the 2-5 Mhz curved array probe in saggital paramedian oblique plane ( saggital paramedian oblique plane is the plane perpendicular to transverse plane and it is another ultrasonic examination technique to visualize the body parts in a different view than transverse plane) in patients undergoing lumbar herniated nucleus pulposus surgery.
Timepoint [2] 305369 0
lumbar epidural space depth will be measured by ultrasound before the operation afterwhen the patient is in the operation room and monitorized.
Secondary outcome [1] 343090 0
measurement of epidural depth from the magnetic resonance imaging of the patients scheduled for lumbar herniated nucleus pulposus surgery. this measurement will be assessed by MRI whereas primary outcomes will be assessed by Ultrasound.
Timepoint [1] 343090 0
magnetic resonance imaging of all patients will be present before the operation in patient database and the measurements will be obtained from the images.
Secondary outcome [2] 343537 0
measurement of actual epidural depth of patients undergoing lumbar herniated nucleus pulposus surgery. The true anatomical epidural depth (actual epidural depth) will be measured with a sterile tape measure from the surgical wound by the surgeon during the surgical exploration and this is the actual epidural depth and no imaging techniques will be used in this measurement.
Timepoint [2] 343537 0
actual epidural depth will be measured by the surgeon with a disposable sterile tape measure upon reaching the dura during surgical exploration.

Eligibility
Key inclusion criteria
patients undergoing elective lumbar herniated nucleus pulposus surgery.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
more than one segment surgery for lumbar herniated nucleus pulposus
emergency cases
patients' refusal to participate in to the study
age <18 years or age> 80 years

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
IBM SPSS ver 21.0 will be used to analyze the data collected. mean, standard deviation, frequencies, median will be used for the analysis of quantitative data. normal distribution of data will be analyzed by Kolmogorov- Smirnow and Shapiro Wilk tests. Spearman's rho correlation and Pearson correlation tests will be used to analyze the correlation between the mesaurements of epidural depth bu ultrasound, magnetic resonance imaging and actual depth

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2018
Actual
31/05/2018
Date of last participant enrolment
Anticipated
31/08/2018
Actual
17/07/2018
Date of last data collection
Anticipated
31/08/2018
Actual
17/07/2018
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 9603 0
Turkey
State/province [1] 9603 0
kirsehir

Funding & Sponsors
Funding source category [1] 298656 0
Self funded/Unfunded
Name [1] 298656 0
mehmet cantürk
Country [1] 298656 0
Turkey
Primary sponsor type
Individual
Name
mehmet cantürk
Address
medical doctor at ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country
Turkey
Secondary sponsor category [1] 297825 0
None
Name [1] 297825 0
none
Address [1] 297825 0
none
Country [1] 297825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299611 0
ahi evran üniversitesi tip fakültesi klinik arastirmalar etik kurulu
Ethics committee address [1] 299611 0
Ethics committee country [1] 299611 0
Turkey
Date submitted for ethics approval [1] 299611 0
15/12/2017
Approval date [1] 299611 0
26/12/2017
Ethics approval number [1] 299611 0
2017-20/244

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81022 0
Dr mehmet cantürk
Address 81022 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country 81022 0
Turkey
Phone 81022 0
+905053574372
Fax 81022 0
Email 81022 0
[email protected]
Contact person for public queries
Name 81023 0
mehmet cantürk
Address 81023 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country 81023 0
Turkey
Phone 81023 0
+905053574372
Fax 81023 0
Email 81023 0
[email protected]
Contact person for scientific queries
Name 81024 0
mehmet cantürk
Address 81024 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country 81024 0
Turkey
Phone 81024 0
+905053574372
Fax 81024 0
Email 81024 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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