Clinical trial NCT04499469: The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
Official title: The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhinoplasty
Nasal Obstruction
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Absence of nasal obstruction;
* Previous nasosinusal surgery;
* Symmetrical or asymmetric insufficiency of the middle third that would justify the placement 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 such as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation correction, otoplasty or blepharoplasty.

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation Scale (NOSE)
timeFrame: 180 postoperative days
Secondary outcomes:
measure: Rhinoplasty Outcome Evaluation (ROE) Scale
timeFrame: 180 postoperative days
measure: Visual Analogue Scale - Nasal Obstruction
timeFrame: 180 postoperative days
measure: Clinical Diagnosis of Allergic Rhinitis
timeFrame: Base line and 180 postoperative days
measure: Complications
timeFrame: 7 until 180 postoperative days
measure: Anterior Rhinoscopy and Nasal Endoscopy
timeFrame: Base line and 180 postoperative days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Raphaella Migliavacca
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Michelle Lavinsky-Wolff, PhD
role: STUDY_DIRECTOR
References: