Clinical trial NCT01457638: Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Outcomes
Official title: Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life and Acoustic Rhinometry Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Rhinoplasty
Rhinoseptoplasty
Turbinate Surgery
Quality of Life
Keywords: nasal obstruction
rhinoplasty
turbinate surgery
quality of life
acoustic rhinometry
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Nasal Obstructive Symptoms Evaluation Scale
timeFrame: 3 months postop
Secondary outcomes:
measure: Acoustic Rhinometry
timeFrame: 3 months post-op
measure: World Health Organization Quality of Life (WHOQOL)
timeFrame: 3 months postop
measure: Rhinoplasty Outcomes Evaluation
timeFrame: 3 months postop
measure: Allergic Conjunctivitis
timeFrame: 3 months postop
measure: Nasal Rhinorrea
timeFrame: 3 months postop
measure: Nasal pruritis
timeFrame: 3 months posopt
measure: Nasal Sneeze
timeFrame: 3 months postop
measure: Topic nasal corticosteroid
timeFrame: 3 months
measure: Oral antihistamine
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre/ Universidade Federal do Rio Grande do Sul
name: Michelle L Wolff
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Carisi A Polanczyck, PhD
role: STUDY_CHAIR
affiliation: Faculdade de Ciências Médicas da Santa Casa de São Paulo
name: José E Dolci, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.