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Clinical Trials/NCT02231216
NCT02231216CompletedNot Applicable

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

Hospital de Clinicas de Porto Alegre2 sites in 1 country50 target enrollmentStarted: March 2014Last updated:
Conditions
Interventions

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

Experimental

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Intervention: Rhinoseptoplasty (Procedure)

Rhinoseptoplasty and turbinectomy

Experimental

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Intervention: Partial turbinectomy (Procedure)

Rhinoseptoplasty and turbinectomy

Experimental

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

Intervention: Endoscopic partial turbinectomy (Procedure)

Rhinoseptoplasty

Active Comparator

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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