Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

Not Applicable

Completed

• Conditions: Deviated Nasal Septum; Nasal Septum, Irregular; Nasal Septal Defect
• Interventions: Procedure: Rhinoseptoplasty; Procedure: Partial turbinectomy; Procedure: Endoscopic partial turbinectomy

• Registration Number: NCT02231216
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-04
• Primary Completion: 2015-03
• Study Completion: 2016-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhinoseptoplasty and turbinectomy	Partial turbinectomy	Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
Rhinoseptoplasty and turbinectomy	Endoscopic partial turbinectomy	Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
Rhinoseptoplasty	Rhinoseptoplasty	Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.
Rhinoseptoplasty and turbinectomy	Rhinoseptoplasty	Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Primary Outcome Measures

Name	Time	Method
Quality of life related to nasal obstruction	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Topical Nasal Corticosteroids	3 MONTHS	At 90 posoperative day patients were asked if they were using topic nasal corticosteroids or not
Nasal sneezing	3 MONTHS	At 90 posoperative day patients were asked if they had nasal sneezing for more than one hour a day on most days, or not.
Nasal Rhinorrhea	3 MONTHS	At 90 posoperative day patients were asked if they had nasal rhinorrhea for more than one hour a day on most days, or not.
Nasal Pruritis	3 MONTHS	At 90 posoperative day patients were asked if they had nasal pruritis for more than one hour a day on most days, or not.
Allergic Conjunctivitis	3 months	At 90 posoperative day patients were asked if they had allergic conjunctivitis for more than one hour a day on most days, or not.
Oral antihistamine	3 months	At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil