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Deviated Nasal SeptumWHOQOL-BREFNCT02231216

Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

A study testing Rhinoseptoplasty, Partial turbinectomy and Endoscopic partial turbinectomy in people with Deviated Nasal Septum and Nasal Septal Defect, 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

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… Read more about this study

Who is it for?
Ages 6 months to 90 years
What is being tested?
Rhinoseptoplasty, Partial turbinectomy and Endoscopic partial turbinectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
Mar 2014to Jul 2016
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 6 months to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eligible patients to rhinoseptoplasty
  • Patients who agreed to participate

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

About this study

Official title: The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life

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
Being tested
Rhinoseptoplasty, Partial turbinectomy, Endoscopic partial turbinectomy
Keywords
rhinoseptoplasty

What participants receive

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

  • RhinoseptoplastyProcedure or surgery

    Rhinoseptoplasty without turbinectomy procedure

  • Partial turbinectomyProcedure or surgery

    Also called 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.

  • Endoscopic partial turbinectomyProcedure or surgery

    Endoscopy to medial dislocation of the inferior turbinate with instrument

Study groups in NCT02231216
Study groupRoleWhat they receive
Rhinoseptoplasty and turbinectomyExperimentalPatients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
Receives: Procedure: Rhinoseptoplasty; Procedure: Partial turbinectomy; Procedure: Endoscopic partial turbinectomy
RhinoseptoplastyActive comparatorPatients submitted only to rhinoseptoplasty, without turbinectomy procedure.
Receives: Procedure: Rhinoseptoplasty

What is being measured

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

  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.

    Measured: 3 months

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3 months

  5. Topical Nasal Corticosteroids

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

    Measured: 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

    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 posted4 Sep 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2015
  4. Study completionJul 2016

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
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231216
Sponsor's protocol ID
130516
Acronym
WHOQOL-BREF
Status last verified
Jan 2019
First submitted
2 Sep 2014
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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Rhinoseptoplasty, Partial turbinectomy and Endoscopic partial turbinectomy in people with Deviated Nasal Septum and Nasal Septal Defect, 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 4 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. 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?

Quality of life related to nasal obstruction (time frame: 3 months). 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 NCT02231216, 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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