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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Nasal Obstruction; Rhinoplasty; Rhinoseptoplasty; Turbinate Surgery
• Intervention / Treatment: Procedure: No iInferior turbinate surgery; Procedure: Inferior turbinate surgery

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Michelle L Wolff, Hospital de Clinicas de Porto Alegre/ Universidade Federal do Rio Grande do Sul; Study Chair: Carisi A Polanczyck, PhD, Federal University of Rio Grande do Sul; Study Chair: José E Dolci, PhD, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

General Publications

• Garcia JPT, Moura BH, Rodrigues VH, Vivan MA, Azevedo SM, Dolci JEL, Migliavacca R, Lavinsky-Wolff M. Inferior Turbinate Reduction during Rhinoplasty: Is There Any Effect on Rhinitis Symptoms? Int Arch Otorhinolaryngol. 2021 Aug 5;26(1):e111-e118. doi: 10.1055/s-0041-1726046. eCollection 2022 Jan.
• Lavinsky-Wolff M, Camargo HL Jr, Barone CR, Rabaioli L, Wolff FH, Dolci JE, Polanczyk CA. Effect of turbinate surgery in rhinoseptoplasty on quality-of-life and acoustic rhinometry outcomes: a randomized clinical trial. Laryngoscope. 2013 Jan;123(1):82-9. doi: 10.1002/lary.23628. Epub 2012 Oct 15.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; rhinoplasty; nasal obstruction; acoustic rhinometry; turbinate surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 1004-20