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WHOQOL-BREF: Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT02231216
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
28
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rhinoseptoplasty
  • Procedure: Partial turbinectomy
  • Procedure: Endoscopic partial turbinectomy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rhinoseptoplasty and turbinectomy

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Procedure: Rhinoseptoplasty
Rhinoseptoplasty without turbinectomy procedure

Procedure: Partial 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.
Other Names:
  • Turbinectomy

    • Procedure: Endoscopic partial turbinectomy
    Endoscopy to medial dislocation of the inferior turbinate with instrument
    Active Comparator: Rhinoseptoplasty

    Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.

    Procedure: Rhinoseptoplasty
    Rhinoseptoplasty without turbinectomy procedure

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life related to nasal obstruction [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 Outcome Measures

    1. Nasal sneezing [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 [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 [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 [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 [3 MONTHS]

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

    6. Oral antihistamine [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035-903

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Bianca H Moura, MD, Hospital de Clínicas de Porto Alegre
    • Principal Investigator: Michelle Lavinsky, PhD, Hospital de Clínicas de Porto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT02231216
    Other Study ID Numbers:
    • 130516
    First Posted:
    Sep 4, 2014
    Last Update Posted:
    Jan 17, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Hospital de Clinicas de Porto Alegre
    rhinoseptoplasty

    Study Results

    No Results Posted as of Jan 17, 2019