Back to resultsInferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Outcomes
Primary Purpose
Nasal Obstruction, Rhinoplasty, Rhinoseptoplasty
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inferior turbinate surgery
No iInferior turbinate surgery
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction focused on measuring nasal obstruction, rhinoplasty, turbinate surgery, quality of life, acoustic rhinometry
Eligibility Criteria
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)
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
No inferior turbinate surgery
Inferior Turbinate surgery
Arm Description
During rhinoseptoplasty there is no intervention on inferior turbinates
During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.
Outcomes
Primary Outcome Measures
Nasal Obstructive Symptoms Evaluation Scale
Specif instrument for evaluation of quality of life related to nasal obstruction
Secondary Outcome Measures
Acoustic Rhinometry
World Health Organization Quality of Life (WHOQOL)
quality of life instrument
Rhinoplasty Outcomes Evaluation
quality of life for rhinoplasty patients
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.
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.
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.
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.
Topic nasal corticosteroid
At 90 posoperative day patients were asked if they were using topic nasal corticosteroid or not.
Oral antihistamine
At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not
Full Information
NCT ID
NCT01457638
First Posted
October 17, 2011
Last Updated
January 16, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01457638
Brief Title
Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Outcomes
Official Title
Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life and Acoustic Rhinometry Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Rhinoplasty, Rhinoseptoplasty, Turbinate Surgery, Quality of Life
Keywords
nasal obstruction, rhinoplasty, turbinate surgery, quality of life, acoustic rhinometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No inferior turbinate surgery
Arm Type
Sham Comparator
Arm Description
During rhinoseptoplasty there is no intervention on inferior turbinates
Arm Title
Inferior Turbinate surgery
Arm Type
Experimental
Arm Description
During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.
Intervention Type
Procedure
Intervention Name(s)
Inferior turbinate surgery
Intervention Description
During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.
Intervention Type
Procedure
Intervention Name(s)
No iInferior turbinate surgery
Intervention Description
During rhinoseptoplasty no intervention is done in inferior turbinates
Primary Outcome Measure Information:
Title
Nasal Obstructive Symptoms Evaluation Scale
Description
Specif instrument for evaluation of quality of life related to nasal obstruction
Time Frame
3 months postop
Secondary Outcome Measure Information:
Title
Acoustic Rhinometry
Time Frame
3 months post-op
Title
World Health Organization Quality of Life (WHOQOL)
Description
quality of life instrument
Time Frame
3 months postop
Title
Rhinoplasty Outcomes Evaluation
Description
quality of life for rhinoplasty patients
Time Frame
3 months postop
Title
Allergic Conjunctivitis
Description
At 90 posoperative day patients were asked if they had allergic conjunctivitis for more than one hour a day on most days, or not.
Time Frame
3 months postop
Title
Nasal Rhinorrea
Description
At 90 posoperative day patients were asked if they had nasal rhinorrea for more than one hour a day on most days, or not.
Time Frame
3 months postop
Title
Nasal pruritis
Description
At 90 posoperative day patients were asked if they had nasal pruritis for more than one hour a day on most days, or not.
Time Frame
3 months posopt
Title
Nasal Sneeze
Description
At 90 posoperative day patients were asked if they had nasal sneeze for more than one hour a day on most days, or not.
Time Frame
3 months postop
Title
Topic nasal corticosteroid
Description
At 90 posoperative day patients were asked if they were using topic nasal corticosteroid or not.
Time Frame
3 months
Title
Oral antihistamine
Description
At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle L Wolff
Organizational Affiliation
Hospital de Clinicas de Porto Alegre/ Universidade Federal do Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carisi A Polanczyck, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José E Dolci, PhD
Organizational Affiliation
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
35096167
Citation
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.
Results Reference
derived
PubMed Identifier
23070968
Citation
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.
Results Reference
derived
Learn more about this trial
Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Outcomes
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