The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment

Last updated: July 31, 2020
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasal Obstruction

Acute Rhinitis

Treatment

N/A

Clinical Study ID

NCT04499469
91672218400005327
  • Ages 14-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it affects quality of life and surgical outcomes. Is the association of middle third grafts with reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal obstruction when compared to reduction rhinoseptoplasty without the placement of these grafts?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients eligible for reduction rhinoseptoplasty who agreed to participate in thestudy and who did not meet the exclusion criteria

Exclusion

Exclusion Criteria:

  • Absence of nasal obstruction;

  • Previous nasosinusal surgery;

  • Symmetrical or asymmetric insufficiency of the middle third that would justify theplacement of middle third grafts for the treatment of these problems;

  • Presence of nasal valve insufficiency as the only cause of nasal obstruction;

  • Cranio-facial anomalies;

  • Presence of nasosinusal tumors;

  • Active acute rhinosinusitis;

  • Patients undergoing treatment of other entities concomitant to rhinoseptoplasty suchas: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforationcorrection, otoplasty or blepharoplasty.

Study Design

Total Participants: 50
Study Start date:
October 03, 2018
Estimated Completion Date:
June 01, 2021

Study Description

Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. The gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.

Connect with a study center

  • Raphaella Migliavacca

    Porto Alegre, RS 90480030
    Brazil

    Active - Recruiting

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