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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457638
• Other study ID #: 1004-20
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nasal Obstruction
• Quality of Life
• Rhinoplasty
• Rhinoseptoplasty
• Turbinate Surgery

Intervention

Procedure:
• Inferior turbinate surgery
During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.
• No iInferior turbinate surgery
During rhinoseptoplasty no intervention is done in inferior turbinates

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Obstructive Symptoms Evaluation Scale	Specif instrument for evaluation of quality of life related to nasal obstruction	3 months postop
Secondary	Acoustic Rhinometry		3 months post-op
Secondary	World Health Organization Quality of Life (WHOQOL)	quality of life instrument	3 months postop
Secondary	Rhinoplasty Outcomes Evaluation	quality of life for rhinoplasty patients	3 months postop
Secondary	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.	3 months postop
Secondary	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.	3 months postop
Secondary	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.	3 months posopt
Secondary	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.	3 months postop
Secondary	Topic nasal corticosteroid	At 90 posoperative day patients were asked if they were using topic nasal corticosteroid or not.	3 months
Secondary	Oral antihistamine	At 90 posoperative day patients were asked if they had used oral antihistamine in the past 30 days or not	3 months