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Completed

NCT Number: NCT02231216

Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

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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Key information

Conditions

Deviated Nasal Septum Nasal Septal Defect Nasal Septum, Irregular

Age range

6 month–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible patients to rhinoseptoplasty
  • Patients who agreed to participate

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.

Treatment and study plan

Rhinoseptoplasty

Procedure

Rhinoseptoplasty without turbinectomy procedure

Partial turbinectomy

Procedure

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.

Other names: Turbinectomy

Endoscopic partial turbinectomy

Procedure

Endoscopy to medial dislocation of the inferior turbinate with instrument

Primary outcomes

  1. Quality of life related to nasal obstruction

    Time frame: 3 months

    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.

Secondary outcomes

  1. Nasal sneezing

    Time frame: 3 MONTHS

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

  2. Nasal Rhinorrhea

    Time frame: 3 MONTHS

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

  3. Nasal Pruritis

    Time frame: 3 MONTHS

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

  4. Allergic Conjunctivitis

    Time frame: 3 months

    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. Topical Nasal Corticosteroids

    Time frame: 3 MONTHS

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

  6. 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

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

Acronym: WHOQOL-BREF

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 4, 2014
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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