Effects of Septorhinoplasty on Allergic Rhinitis

Study Overview
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Brief Summary
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Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still contradictory, because is thought that patients with AR are not able to appreciate improvement after surgery. Patients diagnosed with allergic rinitis and septal deviation were evaluated to determined life quality and airflow obstruction evolution after STP.

Detailed Description
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This is a prospective quasi experimental study. After being informed about the study, patients that signed written informed consent were included in the study. In week 0 before surgery, all measurements and questionnaires were performed. 1 month after surgery, measurements were repeated. After screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psycology and perception of affection by allergic rhinitis. Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use was registered.

Official Title
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Effects of Septorhinoplasty on Allergic Rhinitis Evolution

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Procedure: Septorhinoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Allergic Rhinitis Diagnosis of nasal obstruction with septal deviation Exclusion Criteria: Previous nasal surgery Smokers Chronic obstructive pulmonary disease Psychiatric disorders Malignant tumors Severe hepatopathy Obstructive sleep apnea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective study with 1 months period follow up. Patients with septal deviation and allergic rhinitis diagnosis will be included. Obstruction airflow will be evaluated before and after surgery with rhinomanometry (RNM). Life quality will be assessed with VAS and ESPRINTquestionnaires.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inver<br>Intervention: after screening, patient´s obstruction will be evaluated by anterior rhinomanometry (RNMa), and quality of life wil be scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psychology and perception of affection by allergic rhinitis. Symptoms will be evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileukotrienes, antihistamine eye drops, antihistamine) frequency use will be registered | Procedure: Septorhinoplasty<br>* This intervention will be performed by the same surgeon, after signing of patient inform consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of Airflow rate | Rhinomanometre will be used to determine airflow rate changes before surgery (septoplasty) and after it. Rhinomanometre will determine airflow rate in cm3/s and also use a quality scale as normal, mild, severe and very severe | Change from baseline airflow rate (Before treatment) at 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of symptoms | VAS score. VAS: visual analogue scale. Patients determine their symptoms with a visual scale that range from 0-10. | Changes from baseline (Before treatment) at 1 month after surgery | 
| Changes from baseline in quality of life | ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items. | Changes from baseline (Before treatment) at 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septoplasty, VAS, quality of life, allergic rhinitis, nasal obstruction