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Nasal ObstructionNCT01457638

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

A study testing Inferior turbinate surgery and No iInferior turbinate surgery in people with Nasal Obstruction and Rhinoplasty, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Nasal Obstruction, Rhinoplasty, Rhinoseptoplasty
What is being tested?
Inferior turbinate surgery and No iInferior turbinate surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteBrazil
Study dates
Dec 2010to Oct 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Official title: Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life and Acoustic Rhinometry Outcomes

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.

Being tested
Inferior turbinate surgery, No iInferior turbinate surgery
Keywords
nasal obstruction, rhinoplasty, turbinate surgery, quality of life, acoustic rhinometry
Medical subject headings
Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inferior turbinate surgeryProcedure or surgery

    During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.

  • No iInferior turbinate surgeryProcedure or surgery

    During rhinoseptoplasty no intervention is done in inferior turbinates

Study groups in NCT01457638
Study groupRoleWhat they receive
No inferior turbinate surgerySham comparatorDuring rhinoseptoplasty there is no intervention on inferior turbinates
Receives: Procedure: No iInferior turbinate surgery
Inferior Turbinate surgeryExperimentalDuring rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.
Receives: Procedure: Inferior turbinate surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nasal Obstructive Symptoms Evaluation Scale

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

    Measured: 3 months postop

Secondary outcomes (9)

  1. Acoustic Rhinometry

    Measured: 3 months post-op

  2. World Health Organization Quality of Life (WHOQOL)

    quality of life instrument

    Measured: 3 months postop

  3. Rhinoplasty Outcomes Evaluation

    quality of life for rhinoplasty patients

    Measured: 3 months postop

  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.

    Measured: 3 months postop

  5. Nasal Rhinorrea

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

    Measured: 3 months postop

  6. 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.

    Measured: 3 months posopt

  7. Nasal Sneeze

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

    Measured: 3 months postop

  8. Topic nasal corticosteroid

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

    Measured: 3 months

  9. Oral antihistamine

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01457638
Sponsor's protocol ID
1004-20
Status last verified
Jan 2019
First submitted
17 Oct 2011
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
No

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

  • 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.

    PubMed 23070968

Questions about this trial

What is this clinical trial studying?

A study testing Inferior turbinate surgery and No iInferior turbinate surgery in people with Nasal Obstruction and Rhinoplasty, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nasal Obstructive Symptoms Evaluation Scale (time frame: 3 months postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01457638, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.

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