Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000347167
Ethics application status
Approved
Date submitted
21/02/2019
Date registered
5/03/2019
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Septal Nasal Deviation on carotid intima media thickness
Scientific title
Effect of Septal Nasal Deviation on carotid intima media thickness
Secondary ID [1] 297484 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nasal obstruction 311676 0
Nasal septal deviation 311731 0
Condition category
Condition code
Respiratory 310302 310302 0 0
Other respiratory disorders / diseases
Cardiovascular 310303 310303 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We include patients who require nasal septal surgery due to nasal septal deviation. The septoplasty was performed in these patients. However, septoplasty operation is not part of our study and postoperative results were not evaluated in this study. The VAS scale and NOSE scale will be performed to the patient and control groups due to evaluate subjective nasal obstruction. The measurements and questionnaire about this study were performed before nasal septal surgery(septoplasty). Blood cholesterol levels, electrocardiography, and carotid intima-media thickness measurements with B-mode ultrasonography will be performed in both groups.
The questionnaires take approximately 10 minutes. Additionally, the electrocardiography and carotid intima-media thickness measurements take approximately 20 minutes.
Intervention code [1] 313732 0
Diagnosis / Prognosis
Comparator / control treatment
60 healthy volunteers who haven't nasal obstruction as the control group will be included.Septoplasty was not performed participants of the control group.
Control group
Active

Outcomes
Primary outcome [1] 319189 0
The severity of nasal obstruction will be evaluated VAS scale.
Timepoint [1] 319189 0
Evaluation of Visual Analog Scale (VAS) in both groups will be performed by the otorhinolaryngologist before the initiation of the study.
Primary outcome [2] 319228 0
Assessment of Nasal Obstruction Symptom Evaluation (NOSE) scale in participants
Timepoint [2] 319228 0
Assessment of Nasal Obstruction Symptom Evaluation (NOSE) scale in both groups will be performed by the otorhinolaryngologist before the initiation of the study.
Secondary outcome [1] 367243 0
Electrocardiography measurement will be performed in both groups. The electrocardiography will be performed to define whether cardiac pathology such as arrhythmia, myocardial infarction.
Timepoint [1] 367243 0
Evaluation of the electrocardiography will be performed by the cardiologist in both groups.
Secondary outcome [2] 367384 0
The carotid intima-media thickness measurement with B-mode ultrasonography will be performed in both groups.
Timepoint [2] 367384 0
Assessment of carotid intima-media thickness with B-mode ultrasonography will be performed by the cardiologist in both groups.
Secondary outcome [3] 367564 0
The measurement of blood cholesterol level will be performed in both groups.
Timepoint [3] 367564 0
The measurement will be performed during the preoperative tests in patients.

Eligibility
Key inclusion criteria
Individuals who admitted to our outpatient clinic with the complaint of nasal obstruction and were required septoplasty
as a control group, volunteer individuals without septum deviation or upper airway obstruction
Patients who have BMI under 35
Patients without diagnosed a cardiovascular and pulmonary disease
Patients age: 18-65 years
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. patients used smoking and alcohol
2. DM, Hypertension
3. hypercholesterolemia
4. Coronary artery disease
5. History of myocardial infarction,
6. Active infection
7. Asthma, allergic rhinitis
8. A history of cerebrovascular disease
9. Immune-related diseases (eg ankylosing spondylitis, SLE, Behçet)
10. Under 18 years and over 65 years
11. Chronic sinusitis,
12. Cardiac diseases
13. Chronic obstructive pulmonary disease
14. Using ACE inhibitor, Diuretic, angiotensin II receptor blocker and beta blocker
15.Individuals with BMI> 35
16. Patients with a history of known hyperthyroidism
17.Pregnant women, breastfeeding women and patients with poor general condition

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 21299 0
Turkey
State/province [1] 21299 0
Konya

Funding & Sponsors
Funding source category [1] 302051 0
Hospital
Name [1] 302051 0
Selcuk University, Faculty of medicine hospital
Country [1] 302051 0
Turkey
Primary sponsor type
Hospital
Name
Selcuk University, Faculty of medicine hospital
Address
Akademi Mahallesi Yeni Istanbul Caddesi No:313
Selcuk University Alaeddin Keykubat campus
Selçuklu/Konya
post code:42130
Country
Turkey
Secondary sponsor category [1] 301860 0
None
Name [1] 301860 0
Address [1] 301860 0
Country [1] 301860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302733 0
Selcuk University Faculty of Medicine Ethics committee
Ethics committee address [1] 302733 0
Alaeddin Keykubat Campus, Akademi Mah. Yeni Istanbul Cad. No:369 Post Code:42130 Selçuklu-Konya / TURKEY
Ethics committee country [1] 302733 0
Turkey
Date submitted for ethics approval [1] 302733 0
14/06/2018
Approval date [1] 302733 0
25/07/2018
Ethics approval number [1] 302733 0
2018/281

Summary
Brief summary
Chronic nasal obstruction owing to deviated nasal septum leads to increased upper respiratory tract resistance and this leads to chronic hypoxia. It is reported that chronic hypoxia is associated with atherosclerosis. The aim of this study was to investigate the association of septum deviation that causes of the nasal obstruction with carotid intima-media thickness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91202 0
Dr Bülent Ulusoy
Address 91202 0
Selcuk University, Faculty of medicine hospital
Akademi Mahallesi Yeni Istanbul Caddesi No:313
Selcuk University Alaeddin Keykubat campus
Selçuklu/Konya
post code:42130
Country 91202 0
Turkey
Phone 91202 0
+95065097893
Fax 91202 0
Email 91202 0
[email protected]
Contact person for public queries
Name 91203 0
Dr Bülent Ulusoy
Address 91203 0
Selcuk University, Faculty of medicine hospital
Akademi Mahallesi Yeni Istanbul Caddesi No:313
Selcuk University Alaeddin Keykubat campus
Selçuklu/Konya
post code:42130
Country 91203 0
Turkey
Phone 91203 0
+905065097893
Fax 91203 0
Email 91203 0
[email protected]
Contact person for scientific queries
Name 91204 0
Dr Bülent Ulusoy
Address 91204 0
Selcuk University, Faculty of medicine hospital
Akademi Mahallesi Yeni Istanbul Caddesi No:313
Selcuk University Alaeddin Keykubat campus
Selçuklu/Konya
post code:42130
Country 91204 0
Turkey
Phone 91204 0
+905065097893
Fax 91204 0
Email 91204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


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
No additional documents have been identified.