Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Study Overview
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Brief Summary
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Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery. The aim of the study is to examine nasal airflow parameters after septoplasty and turbinoplasty .

Detailed Description
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Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery. The aim of the study is to examine nasal airflow parameters at pre-defined intervals in patients after septoplasty and turbinoplasty .

Official Title
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Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Conditions
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Nasal Obstruction, Nasal Septum; Deviation, Nasal Mucosa Hypertrophy

Intervention / Treatment
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* Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty
* Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with nasal obstruction (nasal septal deviation, hypertrophy of nasal mucosa) 18 to 70 Years patient capable of general anesthesia signing of the informed consent Exclusion Criteria: - patient incapable of general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septoplasty<br>The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. | Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty<br>* Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.<br>Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty<br>* Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.<br>|
| Experimental: Turbinoplasty<br>The patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. | Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty<br>* Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.<br>Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty<br>* Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.<br>|
| Experimental: Septoplasty and turbinoplasty<br>The patients indicated for septoplasty and turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. | Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty<br>* Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.<br>Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty<br>* Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in resistance | Changes in resistance (measured in Pa-s/ml - Pascal-second/millilitre) will be assessed with rhinomanometry 6 and 12 weeks after surgery. | 6 and 12 weeks after surgery | 
| Changes in airflow | Changes in airflow (measured in ml/s - millilitres/second) will be assessed with rhinomanometry 6 and 12 weeks after surgery. | 6 and 12 weeks after surgery | 
| Changes in the cross-sectional area of the nasal passage | Changes in the cross-sectional area of the nasal passage will be assessed with acoustic rhinometry 6 and 12 weeks after surgery. | 6 and 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal obstruction, septoplasty, turbinoplasty, nasal mucosa, nasal septum