Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

Study Overview
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Brief Summary
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Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate? Population: patients eligible for functional rhinoseptoplasty and / or aesthetic Intervention: surgery, turbinectomy of inferior turbinates Comparison: the absence of intervention in inferior turbinates Primary endpoint: Quality of life related to nasal obstruction

Official Title
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The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life

Conditions
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Deviated Nasal Septum, Nasal Septal Defect, Nasal Septum, Irregular

Intervention / Treatment
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* Procedure: Rhinoseptoplasty
* Procedure: Partial turbinectomy
* Procedure: Endoscopic partial turbinectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients to rhinoseptoplasty Patients who agreed to participate Exclusion Criteria: Presence of symptoms of nasal obstruction in the absence of septal deviation, poor support of the nasal tip or clamping of the nasal valve; Presence of hypertrophic and obstructive inferior turbinates; Presence of sinonasal tumors; Patients undergoing treatment of other concomitant rhinoplasty entities such as inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and blepharoplasty.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhinoseptoplasty and turbinectomy<br>Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy. | Procedure: Rhinoseptoplasty<br>* Rhinoseptoplasty without turbinectomy procedure<br>Procedure: Partial turbinectomy<br>* After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.<br>* Other names: Turbinectomy;Procedure: Endoscopic partial turbinectomy<br>* Endoscopy to medial dislocation of the inferior turbinate with instrument<br>|
| Active Comparator: Rhinoseptoplasty<br>Patients submitted only to rhinoseptoplasty, without turbinectomy procedure. | Procedure: Rhinoseptoplasty<br>* Rhinoseptoplasty without turbinectomy procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life related to nasal obstruction | Quality of life will be evaluated by the WHOQOL-BREF instrument, that comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal sneezing | At 90 posoperative day patients were asked if they had nasal sneezing for more than one hour a day on most days, or not. | 3 MONTHS | 
| Nasal Rhinorrhea | At 90 posoperative day patients were asked if they had nasal rhinorrhea for more than one hour a day on most days, or not. | 3 MONTHS | 
| 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 | 
| 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 | 
| Topical Nasal Corticosteroids | At 90 posoperative day patients were asked if they were using topic nasal corticosteroids 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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rhinoseptoplasty