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CompletedNCT02231216WHOQOL-BREFUpdated Jan 17, 2019

Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

An interventional study of Rhinoseptoplasty and Partial turbinectomy in Deviated Nasal Septum, Nasal Septal Defect and Nasal Septum, Irregular, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 6 Months to 90 Years. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
6 Months to 90 Years
Sex
All
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Study 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
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Conditions studied

  • Deviated Nasal Septum
  • Nasal Septal Defect
  • Nasal Septum, Irregular

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Keywords

  • rhinoseptoplasty
03

In context

Heart Septal Defects

82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 51 interventional studies indexed under Heart Septal Defects.

Browse Heart Septal Defects studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible patients to rhinoseptoplasty
  • Patients who agreed to participate

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Rhinoseptoplasty and turbinectomy

    Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

    Procedure: Rhinoseptoplasty · Procedure: Partial turbinectomy · Procedure: Endoscopic partial turbinectomy

  • Active comparator
    Rhinoseptoplasty

    Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.

    Procedure: Rhinoseptoplasty

Interventions

  • ProcedureRhinoseptoplasty

    Rhinoseptoplasty without turbinectomy procedure

  • ProcedurePartial turbinectomy

    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

  • ProcedureEndoscopic partial turbinectomy

    Endoscopy to medial dislocation of the inferior turbinate with instrument

06

What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  1. Nasal sneezing

    At 90 posoperative day patients were asked if they had nasal sneezing for more than one hour a day on most days, or not.

    Time frame: 3 MONTHS

  2. Nasal Rhinorrhea

    At 90 posoperative day patients were asked if they had nasal rhinorrhea for more than one hour a day on most days, or not.

    Time frame: 3 MONTHS

  3. Nasal Pruritis

    At 90 posoperative day patients were asked if they had nasal pruritis for more than one hour a day on most days, or not.

    Time frame: 3 MONTHS

  4. Allergic Conjunctivitis

    At 90 posoperative day patients were asked if they had allergic conjunctivitis for more than one hour a day on most days, or not.

    Time frame: 3 months

  5. Topical Nasal Corticosteroids

    At 90 posoperative day patients were asked if they were using topic nasal corticosteroids or not

    Time frame: 3 MONTHS

  6. Oral antihistamine

    At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not

    Time frame: 3 months

07

Study locations

1 site
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande Do Sul 90035-903, Brazil
08

References and documents

Publications

  • 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. PubMed 35096167 ↗
  • 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. PubMed 28815717 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02231216
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Sep 4, 2014
Start date
Mar 2014
Primary completion
Mar 2015
Completion
Jul 2016
Last update
Jan 17, 2019

Study contacts

Bianca H Moura, MD
principal investigator · Hospital de Clínicas de Porto Alegre
Michelle Lavinsky, PhD
principal investigator · Hospital de Clínicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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