Effects of Septorhinoplasty on Allergic Rhinitis

NCT ID: NCT04871256

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-03-01

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Septorhinoplasty

Intervention Type: PROCEDURE

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

Interventions

Septorhinoplasty

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade da Coruña

OTHER

Sponsor Role: collaborator

Mario Pérez Sayáns

OTHER

Sponsor Role: lead

Responsible Party

Mario Pérez Sayáns

Proffessor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

AR/STP-UDC

Identifier Type: -

Identifier Source: org_study_id