Effects of Septorhinoplasty on Allergic Rhinitis

NCT04871256 | Completed

• 1 other identifier: AR/STP-UDC
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Septoplasty; VAS; quality of life; allergic rhinitis; nasal obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes from baseline of symptoms

  Changes from baseline (Before treatment) at 1 month after surgery

• Changes from baseline in quality of life

  Changes from baseline (Before treatment) at 1 month after surgery

Study Arms (1)

Inver

EXPERIMENTAL

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

Interventions

Septorhinoplasty PROCEDURE

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

Inver

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Allergic Rhinitis
• Diagnosis of nasal obstruction with septal deviation

You may not qualify if:

• Previous nasal surgery
• Smokers
• Chronic obstructive pulmonary disease
• Psychiatric disorders
• Malignant tumors
• Severe hepatopathy
• Obstructive sleep apnea

Sponsors & Collaborators

• Mario Pérez Sayáns: lead
• Universidade da Coruña: collaborator

Study Sites (1)

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, 15785, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Nasal Obstruction

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Proffessor

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: May 4, 2021
• Study Start: January 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)