Effects of Septorhinoplasty on Allergic Rhinitis

Sponsor

Mario Pérez Sayáns (Other)

Overall Status

Completed

CT.gov ID

NCT04871256

Collaborator

Universidade da Coruña (Other)

Enrollment

Location

Arm

1.9

Actual Duration (Months)

26.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Procedure: Septorhinoplasty	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

Effects of Septorhinoplasty on Allergic Rhinitis Evolution

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inver 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 This intervention will be performed by the same surgeon, after signing of patient inform consent.

Arm

Intervention/Treatment

Experimental: Inver

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

This intervention will be performed by the same surgeon, after signing of patient inform consent.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.