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

Not Applicable

Completed

• Conditions: Rhinoplasty; Quality of Life; Rhinoseptoplasty; Turbinate Surgery; Nasal Obstruction
• Interventions: Procedure: No iInferior turbinate surgery; Procedure: Inferior turbinate surgery

• Registration Number: NCT01457638
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• 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

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No inferior turbinate surgery	No iInferior turbinate surgery	During rhinoseptoplasty there is no intervention on inferior turbinates
Inferior Turbinate surgery	Inferior turbinate surgery	During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.

Primary Outcome Measures

Name	Time	Method
Nasal Obstructive Symptoms Evaluation Scale	3 months postop	Specif instrument for evaluation of quality of life related to nasal obstruction

Secondary Outcome Measures

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