Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty (WHOQOL-BREF)

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

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

Study Overview

• Status: Completed
• Conditions: Deviated Nasal Septum; Nasal Septal Defect; Nasal Septum, Irregular
• Intervention / Treatment: Procedure: Rhinoseptoplasty; Procedure: Partial turbinectomy; Procedure: Endoscopic partial turbinectomy

• 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, 90035-903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rhinoseptoplasty and turbinectomy; Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.	Procedure: Rhinoseptoplasty; Rhinoseptoplasty without turbinectomy procedure; Procedure: Partial turbinectomy; 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.; Other Names: Turbinectomy; Procedure: Endoscopic partial turbinectomy; Endoscopy to medial dislocation of the inferior turbinate with instrument
ACTIVE_COMPARATOR: Rhinoseptoplasty; Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.	Procedure: Rhinoseptoplasty; Rhinoseptoplasty without turbinectomy procedure

What is the study measuring?

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
Oral antihistamine	At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not	3 months
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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Bianca H Moura, MD, Hospital de Clinicas de Porto Alegre; Principal Investigator: Michelle Lavinsky, PhD, Hospital de Clinicas de Porto Alegre

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.
• de Moura BH, Migliavacca RO, Lima RK, Dolci JEL, Becker M, Feijo C, Brauwers E, Lavinsky-Wolff M. Partial inferior turbinectomy in rhinoseptoplasty has no effect in quality-of-life outcomes: A randomized clinical trial. Laryngoscope. 2018 Jan;128(1):57-63. doi: 10.1002/lary.26831. Epub 2017 Aug 16.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (ESTIMATE): September 4, 2014

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: rhinoseptoplasty
• Other Study ID Numbers: 130516