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OpenTrials
Completed

NCT Number: NCT04871256

Effects of Septorhinoplasty on Allergic Rhinitis

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, 15785, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

septorhinoplasty

Procedure

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

Primary outcomes

  1. Changes from baseline of Airflow rate

    Time frame: 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 outcomes

  1. Changes from baseline of symptoms

    Time frame: 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.

  2. Changes from baseline in quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mario Pérez Sayáns

Other

Collaborators

  • Universidade da Coruña

Registry information

Official study title

Effects of Septorhinoplasty on Allergic Rhinitis Evolution

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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