NCT02231216

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

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 Mar 2014

Typical duration 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

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

September 2, 2014

Last Update Submit

January 16, 2019

Conditions

Deviated Nasal SeptumNasal Septal DefectNasal Septum, Irregular

Keywords

rhinoseptoplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Nasal sneezing

    3 MONTHS

  • Nasal Rhinorrhea

    3 MONTHS

  • Nasal Pruritis

    3 MONTHS

  • Allergic Conjunctivitis

    3 months

  • Topical Nasal Corticosteroids

    3 MONTHS

  • +1 more secondary outcomes

Study Arms (2)

Rhinoseptoplasty and turbinectomy

EXPERIMENTAL

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Procedure: RhinoseptoplastyProcedure: Partial turbinectomyProcedure: Endoscopic partial turbinectomy

Rhinoseptoplasty

ACTIVE COMPARATOR

Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.

Procedure: Rhinoseptoplasty

Interventions

RhinoseptoplastyPROCEDURE

Rhinoseptoplasty without turbinectomy procedure

RhinoseptoplastyRhinoseptoplasty and turbinectomy
Partial turbinectomyPROCEDURE

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.

Also known as: Turbinectomy
Rhinoseptoplasty and turbinectomy
Endoscopic partial turbinectomyPROCEDURE

Endoscopy to medial dislocation of the inferior turbinate with instrument

Rhinoseptoplasty and turbinectomy

Eligibility Criteria

Age6 Months - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients to rhinoseptoplasty
  • Patients who agreed to participate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, 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

  • 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.

    PMID: 28815717DERIVED

Study Officials

  • Bianca H Moura, MD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Michelle Lavinsky, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 4, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

July 1, 2016

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

BR(1)