Clinical trial NCT04871256: Effects of Septorhinoplasty on Allergic Rhinitis
Official title: Effects of Septorhinoplasty on Allergic Rhinitis Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Septoplasty
VAS
quality of life
allergic rhinitis
nasal obstruction
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Universidade da Coruña
First posted: 2021-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes from baseline of Airflow rate
timeFrame: Change from baseline airflow rate (Before treatment) at 1 month after surgery
Secondary outcomes:
measure: Changes from baseline of symptoms
timeFrame: Changes from baseline (Before treatment) at 1 month after surgery
measure: Changes from baseline in quality of life
timeFrame: Changes from baseline (Before treatment) at 1 month after surgery
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Mario Pérez Sayáns
state: A Coruña
Study officials:
References: