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Completed

NCT Number: NCT01457638

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

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Key information

Conditions

Nasal Obstruction Airway Obstruction Nose Diseases Otorhinolaryngologic Diseases Quality of Life Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Rhinoplasty Rhinoseptoplasty Turbinate Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Inferior turbinate surgery

Procedure

During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.

No iInferior turbinate surgery

Procedure

During rhinoseptoplasty no intervention is done in inferior turbinates

Primary outcomes

  1. Nasal Obstructive Symptoms Evaluation Scale

    Time frame: 3 months postop

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

Secondary outcomes

  1. Acoustic Rhinometry

    Time frame: 3 months post-op

  2. World Health Organization Quality of Life (WHOQOL)

    Time frame: 3 months postop

    quality of life instrument

  3. Rhinoplasty Outcomes Evaluation

    Time frame: 3 months postop

    quality of life for rhinoplasty patients

  4. Allergic Conjunctivitis

    Time frame: 3 months postop

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

  5. Nasal Rhinorrea

    Time frame: 3 months postop

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

  6. Nasal pruritis

    Time frame: 3 months posopt

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

  7. Nasal Sneeze

    Time frame: 3 months postop

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

  8. Topic nasal corticosteroid

    Time frame: 3 months

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

  9. Oral antihistamine

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 24, 2011
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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