NCT01457638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

October 17, 2011

Last Update Submit

January 16, 2019

Conditions

Nasal ObstructionRhinoplastyRhinoseptoplastyTurbinate SurgeryQuality of Life

Keywords

nasal obstructionrhinoplastyturbinate surgeryquality of lifeacoustic rhinometry

Outcome Measures

Primary Outcomes (1)

  • Nasal Obstructive Symptoms Evaluation Scale

    Specif instrument for evaluation of quality of life related to nasal obstruction

    3 months postop

Secondary Outcomes (9)

  • Acoustic Rhinometry

    3 months post-op

  • World Health Organization Quality of Life (WHOQOL)

    3 months postop

  • Rhinoplasty Outcomes Evaluation

    3 months postop

  • Allergic Conjunctivitis

    3 months postop

  • Nasal Rhinorrea

    3 months postop

  • +4 more secondary outcomes

Study Arms (2)

No inferior turbinate surgery

SHAM COMPARATOR

During rhinoseptoplasty there is no intervention on inferior turbinates

Procedure: No iInferior turbinate surgery

Inferior Turbinate surgery

EXPERIMENTAL

During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.

Procedure: Inferior turbinate surgery

Interventions

Inferior turbinate surgeryPROCEDURE

During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.

Inferior Turbinate surgery
No iInferior turbinate surgeryPROCEDURE

During rhinoseptoplasty no intervention is done in inferior turbinates

No inferior turbinate surgery

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 15 years old;
  • Nasal obstruction and nasal aesthetics complaints;

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 35096167DERIVED

  • 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.

    PMID: 23070968DERIVED

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Michelle L Wolff

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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 24, 2011

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

BR(1)