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Effects of Septorhinoplasty on Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Septorhinoplasty
Sponsored by
Mario Pérez Sayáns
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Septoplasty, VAS, quality of life, allergic rhinitis, nasal obstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mario Pérez Sayáns

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inver

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 in quality of life
ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items.

Full Information

First Posted
January 14, 2021
Last Updated
April 28, 2021
Sponsor
Mario Pérez Sayáns
Collaborators
Universidade da Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT04871256
Brief Title
Effects of Septorhinoplasty on Allergic Rhinitis
Official Title
Effects of Septorhinoplasty on Allergic Rhinitis Evolution
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mario Pérez Sayáns
Collaborators
Universidade da Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Septoplasty, VAS, quality of life, allergic rhinitis, nasal obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inver
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Septorhinoplasty
Intervention Description
This intervention will be performed by the same surgeon, after signing of patient inform consent.
Primary Outcome Measure Information:
Title
Changes from baseline of Airflow rate
Description
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
Time Frame
Change from baseline airflow rate (Before treatment) at 1 month after surgery
Secondary Outcome Measure Information:
Title
Changes from baseline of symptoms
Description
VAS score. VAS: visual analogue scale. Patients determine their symptoms with a visual scale that range from 0-10.
Time Frame
Changes from baseline (Before treatment) at 1 month after surgery
Title
Changes from baseline in quality of life
Description
ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items.
Time Frame
Changes from baseline (Before treatment) at 1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mario Pérez Sayáns
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15785
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be shared by articles publication.

Learn more about this trial

Effects of Septorhinoplasty on Allergic Rhinitis

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