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

NCT ID: NCT01457638

Last Updated: 2019-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Nasal Obstruction Rhinoplasty Rhinoseptoplasty Turbinate Surgery Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No inferior turbinate surgery

During rhinoseptoplasty there is no intervention on inferior turbinates

Group Type SHAM_COMPARATOR

No iInferior turbinate surgery

Intervention Type PROCEDURE

During rhinoseptoplasty no intervention is done in inferior turbinates

Inferior Turbinate surgery

During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.

Group Type EXPERIMENTAL

Inferior turbinate surgery

Intervention Type PROCEDURE

During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.

Interventions

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Inferior turbinate surgery

During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.

Intervention Type PROCEDURE

No iInferior turbinate surgery

During rhinoseptoplasty no intervention is done in inferior turbinates

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle L Wolff

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre/ Universidade Federal do Rio Grande do Sul

Carisi A Polanczyck, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

José E Dolci, PhD

Role: STUDY_CHAIR

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 35096167 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23070968 (View on PubMed)

Other Identifiers

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1004-20

Identifier Type: -

Identifier Source: org_study_id

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