Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to determine whether inferior turbinate surgery during rhinoseptoplasty is effective in improving quality of life and acoustic rhinometry outcomes.

Official Title
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Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life and Acoustic Rhinometry Outcomes

Conditions
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Nasal Obstruction, Rhinoplasty, Rhinoseptoplasty, Turbinate Surgery, Quality of Life

Intervention / Treatment
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* Procedure: Inferior turbinate surgery
* Procedure: No iInferior turbinate surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 15 years old; Nasal obstruction and nasal aesthetics complaints; Exclusion Criteria: Previous septoplasty, turbinates intervention and/or rhinoplasty; Association of other surgical procedures in the same surgical time, as functional endoscopic sinus surgery, blepharoplasty, mentoplasty or otoplasty; Inferior turbinate hypertrophy as the isolated cause of nasal obstruction (no septum deviation or internal valve collapse)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: No inferior turbinate surgery<br>During rhinoseptoplasty there is no intervention on inferior turbinates | Procedure: No iInferior turbinate surgery<br>* During rhinoseptoplasty no intervention is done in inferior turbinates<br>|
| Experimental: Inferior Turbinate surgery<br>During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed. | Procedure: Inferior turbinate surgery<br>* During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Obstructive Symptoms Evaluation Scale | Specif instrument for evaluation of quality of life related to nasal obstruction | 3 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acoustic Rhinometry |  | 3 months post-op | 
| World Health Organization Quality of Life (WHOQOL) | quality of life instrument | 3 months postop | 
| Rhinoplasty Outcomes Evaluation | quality of life for rhinoplasty patients | 3 months postop | 
| Allergic Conjunctivitis | At 90 posoperative day patients were asked if they had allergic conjunctivitis for more than one hour a day on most days, or not. | 3 months postop | 
| Nasal Rhinorrea | At 90 posoperative day patients were asked if they had nasal rhinorrea for more than one hour a day on most days, or not. | 3 months postop | 
| Nasal pruritis | At 90 posoperative day patients were asked if they had nasal pruritis for more than one hour a day on most days, or not. | 3 months posopt | 
| Nasal Sneeze | At 90 posoperative day patients were asked if they had nasal sneeze for more than one hour a day on most days, or not. | 3 months postop | 
| Topic nasal corticosteroid | At 90 posoperative day patients were asked if they were using topic nasal corticosteroid or not. | 3 months | 
| Oral antihistamine | At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal obstruction, rhinoplasty, turbinate surgery, quality of life, acoustic rhinometry