Clinical trial NCT02231216: Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty
Official title: The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deviated Nasal Septum
Nasal Septal Defect
Nasal Septum, Irregular
Keywords: rhinoseptoplasty
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life related to nasal obstruction
timeFrame: 3 months
Secondary outcomes:
measure: Nasal sneezing
timeFrame: 3 MONTHS
measure: Nasal Rhinorrhea
timeFrame: 3 MONTHS
measure: Nasal Pruritis
timeFrame: 3 MONTHS
measure: Allergic Conjunctivitis
timeFrame: 3 months
measure: Topical Nasal Corticosteroids
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 Clínicas de Porto Alegre
name: Bianca H Moura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Michelle Lavinsky, PhD
role: PRINCIPAL_INVESTIGATOR
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: 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.