Effects of Septorhinoplasty on Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

Effects of Septorhinoplasty on Allergic Rhinitis Evolution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871256
• Other study ID #: AR/STP-UDC
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Spain	Mario Pérez Sayáns	Santiago De Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
Mario Pérez Sayáns	Universidade da Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline of symptoms	VAS score. VAS: visual analogue scale. Patients determine their symptoms with a visual scale that range from 0-10.	Changes from baseline (Before treatment) at 1 month after surgery
Secondary	Changes from baseline in quality of life	ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items.	Changes from baseline (Before treatment) at 1 month after surgery