Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

Deviated Nasal Septum Clinical Trial

— WHOQOL-BREF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231216
• Other study ID #: 130516
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 2016

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deviated Nasal Septum
• Heart Septal Defects
• Nasal Septal Defect
• Nasal Septum, Irregular

Intervention

Procedure:
• Rhinoseptoplasty
Rhinoseptoplasty without turbinectomy 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.
• Endoscopic partial turbinectomy
Endoscopy to medial dislocation of the inferior turbinate with instrument

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	Quality of life related to nasal obstruction	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.	3 months
Secondary	Nasal sneezing	At 90 posoperative day patients were asked if they had nasal sneezing for more than one hour a day on most days, or not.	3 MONTHS
Secondary	Nasal Rhinorrhea	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 MONTHS
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
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
Secondary	Topical Nasal Corticosteroids	At 90 posoperative day patients were asked if they were using topic nasal corticosteroids 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