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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2021-06-01

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Rhinoplasty Nasal Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Spreader Graft

Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose

Group Type EXPERIMENTAL

Spreader Graft

Intervention Type PROCEDURE

To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose

Without Spreader Graft

No engraftment in the middle third

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spreader Graft

To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose

Intervention Type PROCEDURE

Other Intervention Names

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Middle Third Grafts

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes