Allergic Rhinitis
Conditions
Keywords
Septoplasty, VAS, quality of life, allergic rhinitis, nasal obstruction
Brief summary
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
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.
Interventions
PROCEDURESeptorhinoplasty
This intervention will be performed by the same surgeon, after signing of patient inform consent.
Sponsors
Universidade da Coruña
Mario Pérez Sayáns
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of Airflow rate | Change from baseline airflow rate (Before treatment) at 1 month after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of symptoms | Changes from baseline (Before treatment) at 1 month after surgery | VAS score. VAS: visual analogue scale. Patients determine their symptoms with a visual scale that range from 0-10. |
| Changes from baseline in quality of life | Changes from baseline (Before treatment) at 1 month after surgery | ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items. |
Countries
Spain
Outcome results
None listed