Effects of Septorhinoplasty on Allergic Rhinitis Evolution
Phase: NA
Conditions: Allergic Rhinitis
Sponsor: Mario Pérez Sayáns

 
Version: 2], date 30/06/2015 
 
 
 
 
Title: Effects of Septorhinoplasty on Allergic Rhinitis 
Abbreviations: AR: allergic rhinitis; DS: septal deviation; VAS: visual analogue scale; RNMa: 
anterior rhinomanometry; QoL: quality of life; ADL: Basic activities of daily life. 
Introduction: Allergic rhinitis (AR) is a chronic inflammatory disease that affects 
almost 30% of adult population and is associated to other inflammatory disease (1). In 
AR, upper airway respiratory mucosa is inflamed in response to allergen exposition, 
mediated by Th2 immunology response. Common symptoms are sneezing, rhinorrhoea, 
nasal congestion, nasal itching and nasal obstruction. Nasal obstruction is the most 
refractory symptom to medical treatment (2). AR evolution includes chronic 
rhinosinusitis, nasal poliposis or chronic rhinitis (3). Despite its prevalence and the 
variety of medication to treat AR, many patients still feel failure treatment (4). Many 
studies have demonstrated how AR impairs life quality and work productivity, since it 
is an important cause of absence from work and school, and generates huge costs in 
prescription medication (5).  
Nasal septum deviation (DS) causes symptoms as nasal obstruction, epistasis, snoring, 
anxiety, headaches, buccal breathing and sinusitis (6, 7). Septorhinopasty (STP) is the 
most common treatment for patients with DS with generally satisfactory outcomes (8). 
AR treatment include a great variety of medication as antihistamines, anti-leukotrienes, 
corticoids or specific allergen immunotherapy. This conservative method implies 
improvement´s symptoms but in some refractory patients’ medication alone is not 
enough. Surgical procedures to treat AR includes cryotherapy, laser cautery, sinus 
surgery or turbinate resection. AR guides do not include nowadays STP as therapeutic 
possibility, as its outcomes do not resulted as satisfactory as in patients that only show 
DS (9).  
Some authors as Youn HyoKim et al. (2011) studied in two different AR groups how 
STP and turbinoplasty or turbionplasty alone affected to patient´s evolution disease 
(10). In this study they observed a medication reduction in both groups and better scores 
in VAS (visual analogue scale), although there was no airflow measurement. 
Current guides of AR underscore the necessity of research regarding the role of STP in 
the treatment of AR (11). 
Our main objective is to evaluate  
 

 
Version: 2], date 30/06/2015 
 
Material and methods: Patients 
Study Design: This will be a prospective quasi experimental non-randomized controlled 
pre and post-test study. Informed consent (see page 5) will be obtained from all patients 
in accordance with the Declaration of Helsinki of 1975, revised in 2013. This study has 
been approved by the Regional Research Ethics Committee of Galicia (Ref: 2015/280). 
Patients will be recruited in January 2021 and operated in Allergology and 
Otorhinolaryngology service in CHUAC (A Coruña University Hospital) in January 
2021.  
Inclusion criteria: patients aged 18-65, diagnosed with AR and DS, will be recruited. 
DS will be determined by rhinoscopy findings. AR diagnosis will be stablished 
clinically (history and physical examination) and testing for specific allergen 
sensitization (positivity > 3 mm). Studied allergen will be pollen, dust mite and fungi. 
Symptoms of AR should have at least 1 year evolution. AR Classification will be 
performed according to Aria 2008 (12), as “Intermittent AR” (less than 4 days per week 
symptoms) and “Permanent AR” (more than 4 days per week symptoms).  
Patients with none of these symptoms will be recorded as mild nasal obstruction: 
sleeping disorders, daily activity impairment, absence with work or school. If the patient 
had any of those symptoms were classified as moderate-severe nasal obstruction. 
Exclusion criteria: Patients with less than 1-year AR symptoms, patients treated with 
specific immunotherapy against allergen, patients undergoing simultaneous surgical 
procedure (e.g. turbinate reduction), smokers, chronic obstructive pulmonary disease, 
psychiatric disorders, malignant tumours, severe hepatopathy, obstructive sleep apnoea, 
previous nasal surgery.  
Intervention: patients will be screened and surgical procedure will be performed by the 
same surgeon. Variables will be collected from clinical history before and one month 
after surgery.  
After screening, patient´s obstruction will be evaluated by anterior rhinomanometry 
(aRNM) (cm3/s) with Rhinospir Pro-165 Sibelmed® (Barcelona, Spain). Classification 
from mild, moderate, severe or very severe will be determined according to 
Rhinomanometric grading. 
Quality of life (QoF) will be scored through ESPRINT scale. ESPRINT is a validated 
Spanish questionnaire about daily life activity, sleep, psychology and affection´s 
perception in AR patients (13). 

 
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Symptoms like sneezing, itchy nose, ocular symptoms and nasal obstruction will be 
evaluated with visual analogue scale (VAS) and clinical history. VAS score will be 
classified as mild (1-3), moderate (4-6) and severe (7-10).  
Medication (intranasal corticosteroid, ant leukotrienes, antihistamine eye drops, 
antihistamine) and its frequency (less than 2 intakes per week or more than 2 intakes per 
week) will also be registered.  
 
 
 
 

 
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Statistical analysis Plan 
 
Sample size justification: If we estimate in relation to the response variable "severity" 
that 60% of the patients before the intervention present moderate-severe rhinitis and this 
percentage is expected to be reduced to 30% after 12 months, 51 patients would be 
needed to detect this difference as statistically significant with 95% certainty, a 
statistical power of 80% before a bilateral approach of paired data. 
 
All data will be collected in a data base and analysed with SPSS version 20.0 (SPSS 
Inc. Chicago, Illinois). 
Deviation (SD) or interquartile range will be used to describe quantitative variables. For 
categorical variables, the frequency and percentage will be used. Sample normality will 
be assessed using the Kolmogorov-Smirnov test. The univariate analysis will be used 
for comparing measures, either the Student´s t-distribution or the Mann Whitney U test 
depending on the application conditions; for comparing proportions, the chi-squared test 
or Fisher´s exact test will be used. A correlation study will be carried out between 
quantitative variables using the Fisher or Spearman´s statistical test, according to the 
application conditions. Significance will be set at p < 0.05. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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INFORMED CONSENT 
STUDY TITLE: IMPACT ON THE CLINICAL COURSE OF ALLERGIC RHINITIS AFTER 
SEPTOPLASTY. 
 
RESEARCHER: VANESA GARCÍA PAZ 
CENTER: CHUAC 
 
The purpose of this document is to provide you with information about a research study in which 
you are invited to participate. This study was approved by the Research Ethics Committee of 
the Galician Health Sciences. 
If you decide to participate in it, you should receive personalized information from the 
researcher, read this document first, and ask all the questions you need to understand the 
details about it. If you wish, you can take the document with you, consult with others, and take 
the time to decide whether or not to participate. 
Participation in this study is completely voluntary. Vd. you may decide not to participate or, if 
you agree to do so, change your mind by withdrawing consent at any time without obligation to 
give explanations. We assure you that this decision will not affect the relationship with your 
doctor or the health care that you. you are entitled. 
 
What is the purpose of the study? 
With this study we try to see if the septoplasty surgery you are going to undergo for your septal 
deviation, modifies the clinical course of your allergic rhinitis. Check if after surgery you will have 
fewer symptoms of allergic rhinitis, use less medication and ultimately, if you are feeling better, 
if you have a better quality of life than before surgery. We therefore need the voluntary 
participation of people like you who have allergic rhinitis and are going to undergo septoplasty 
surgery for their septal deviation or have already been operated on for it. 
 
Why do they offer to participate in me? 
You are invited to participate because you suffer / are diagnosed with allergic rhinitis and you 
are also waiting to be operated on for septoplasty due to your septal deviation or have already 
been operated on for septoplasty. 
 
What does my participation consist of? 
 Your participation in this study does not vary from the usual clinical practice in terms of hospital 
visits, you will go to the consultation before surgery with the otolaryngologist and in that 
consultation we will take the opportunity to pass a quality of life questionnaire before surgery, 
also a test called rhinomanometry it is already usually done to patients who are going to have 
septoplasty surgery to check what the nasal respiratory flow is like before the operation and 
they will be asked about the medication they use for allergic rhinitis. 
 
After the surgery you will go for check-ups with your otolaryngologist and on one of these visits, 
approximately one year after the surgery, you will have the rhinomanometry repeated, we will 
ask you again about the medication you use for allergic rhinitis and again you will be asked to fill 
in a quality of life questionnaire for patients with allergic rhinitis. 
 
 

 
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Your participation will have an estimated total duration of: the time it takes to complete the 
quality of life questionnaire in patients with allergic rhinitis that only takes a few minutes 
because the rhinomanometry test and questions about how you are and the medication you use 
are part of medical history and tests at regular consultation. 
 
 
What inconveniences or inconveniences does my participation have? 
Your participation in the study should not be a nuisance or too much of an inconvenience for 
you, except in the case of completing a quality of life questionnaire in patients with allergic 
rhinitis, which consists of 15 questions about how you feel about your rhinitis symptoms..  
Will I get any benefit from participating? 
You are not expected to get direct benefit by participating in the study. The research 
aims to uncover unknown or unclear aspects about the changes that septoplasty surgery 
can produce in the clinical course of allergic rhinitis. This information may be useful in 
the future for other people. 
Will I receive the information obtained from the study? 
If desired, a summary of the study results will be provided. 
Will the results of this study be published? 
The results of this study will be sent to scientific publications for dissemination, but no 
data will be transmitted that could lead to the identification of participants. 
How will the confidentiality of my data be protected? 
The processing, communication and transfer of your data will be carried out in 
accordance with the provisions of Organic Law 15/1999, of 13 December, on the 
protection of personal data. At all times, you you may access, oppose, correct or cancel 
your data by requesting it from the researcher. This will not be possible in the event that 
they are collected anonymously or will be anonymized after collection. 
Only the research team, and the health authorities, who have a duty to maintain 
confidentiality, will have access to all the data collected by the study. Information that 
cannot be identified may be transmitted to third parties. In the event that any 
information is transmitted to other countries, it will be carried out with a level of data 
protection equivalent, at least, to that required by the regulations of our country. 
Your data will be collected and stored until the end of the study as follows: 
- Anonymized, that is, that any link that could identify the donor of the data has been 
broken, and cannot be identified even by the research team. 
The person in charge of data custody is Vanesa García Paz. At the end of the study the 
data will be anonymized (will not apply if they have already been collected anonymized).  
Are there economic interests in this study?  
The researcher will not receive specific remuneration for dedication to the study. 
You will not be reimbursed for participating. No commercial products or patents will be 
derived from the results of the study.  
How to contact the research team of this study?  
You can contact Vanesa García Paz at the email address vanesa.garcia.paz@sergas.es. 
Thank you so much for your collaboration. 
 
 
 
 

 
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