Effects of Septorhinoplasty on Allergic Rhinitis

Not Applicable

Completed

• Conditions: Allergic Rhinitis
• Interventions: Procedure: Septorhinoplasty

• Registration Number: NCT04871256
• Lead Sponsor: Mario Pérez Sayáns

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-14
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-28
• Last Update Submitted: 2021-04-28
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inver	Septorhinoplasty	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Mario Pérez Sayáns; 🇪🇸 Santiago De Compostela, A Coruña, Spain