The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Quality of life related to nasal obstruction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Months to 90 Years (Child, Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Rhinoseptoplasty and turbinectomy
Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
Intervention: Rhinoseptoplasty (Procedure)
Rhinoseptoplasty and turbinectomy
Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
Intervention: Partial turbinectomy (Procedure)
Rhinoseptoplasty and turbinectomy
Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
Intervention: Endoscopic partial turbinectomy (Procedure)
Rhinoseptoplasty
Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.
Intervention: Rhinoseptoplasty (Procedure)
Outcomes
Primary Outcomes
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
- Topical Nasal Corticosteroids(3 MONTHS)
- Nasal sneezing(3 MONTHS)
- Nasal Rhinorrhea(3 MONTHS)
- Nasal Pruritis(3 MONTHS)
- Allergic Conjunctivitis(3 months)
- Oral antihistamine(3 months)