Clinical trial NCT03213548: Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty
Official title: Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhinoplasty
Surgical Procedure, Unspecified
Surgery, Plastic
Cicatrix
Healing Scar
Keywords: alar base reduction
alar facial groove
alectomy
Flare
Nose
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind clinical trial
Primary purpose: TREATMENT

Brief summary: Rhinoplasty is among the most accomplished aesthetic procedures in Plastic Surgery. The mastery of Alar Base modifications is essential for superior aesthetic results. The main indication is to reduce nasal width when it exceeds the intercanthal distance in Caucasian women. Other indications are the modification of the shape of the nostrils or to reduce alar flare in noses with too convex alar base. Since Wier's first description, a series of techniques has been developed with a common goal of making the basal view of the nose close to an equilateral triangle. The location and amount of tissue to be removed will be according to the preoperative or intraoperative indication due to changes in the alar base resulting from reductions in the projection of the nasal tip. One of the controversies in the literature is in the position of the incision in alar base modifications. Some authors prioritize incisions that do not violate the alar facial groove , since the groove region presents a greater number of sebaceous glands, leading to poor scarring results. Other authors have argued that incisions above the sulcus have caused more evident scars, anda that poor healing results would be more associated with aggressive resections of border and bad closing skin techniques.

Due to divergence in the literature, the present study aims to compare, through a double blinded randomized clinical trial, two techniques of alar base modifications that will differentiate only by violating or not the alar facial groove.

Detailed description: The study was performed at the Otorhinolaryngology service Clinicas Hospital of Porto Alegre ( HCPA). Patients who meet the inclusion and exclusion criteria will be invited to participate in the study. All patients who agree to participate in the study, filling out an Informed Consent Form, will have their preoperative consultation registered. Pre- and postoperative follow-up will be performed at the otorhinolaryngology service of HCPA. Patients will be allocated randomly in the intervention and control groups, in blocks of 6, using a computer generated random sequence of numbers. . The allocation will be kept confidential for the patient and for the researchers responsible for measuring the outcomes. intervention group will be submitted to surgical modification of the alar base with incisions in the alar facial groove, the control group will be submitted to a similar technique, but it will save groove.

The surgical technique will be based on a sequential approach based on the 2010 publication Adamnson et al in the Archives of Facial Plastic Surgery "Alar Soft-Tissue Techniques in Rhinoplasty Algorithmic Approach, Quantifiable Measurement of outcomes will be performed by trained and blinded research team members for intervention allocation. Patients will be evaluated at the preoperative visit, and will return to consultations on days 7, 14.30, 60, 90.360 postoperative days, when they will be photographed at the incidences, frontal, ¾ profile, basal, between tip with Eyebrows. At the base line and at 90 postoperative days the following outcomes will be measured: Stony Brook Scale , ROE Scale, Visual Analogue Scale - Satisfaction with aesthetic aspect of the nose, Visual Analogue Scale Intensity of nasal obstruction and NOSE Scale For the comparison of continuous variables will be compared using Student's t test for independent samples or Mann-Whitney non-parametric test, when appropriate. Multivariate analysis will be performed to control confounding factors.

Eligibility criteria: Inclusion Criteria:

* Patients from The Department of Otolaryngology of HCPA Hospital who are candidates for functional and / or aesthetic rhinoplasty over 16 years of age, with an indication of alar base modification, will be candidates for the study.

The alar base modification is indicated when the columella-alar distance is greater than the intercanthal distance, when there is presence of asymmetries between the nostrils or its size is too width. In corrections of overprojected noses, there may be enlargement of the base of the alar, with an indication of reduction of the width of the alar at the end of the procedure.

Exclusion Criteria:

* Patients who present (1) Previous alar base surgery modification ; (2) keloid / hypertrophic scar history and (3) Patients with cheek - alar border obtuse angle

Primary outcomes:
measure: Stony Brook Scar Evaluation Scale (SBSES)
timeFrame: 90 days
Secondary outcomes:
measure: Rhinoplasty Outcome Evaluation (ROE) Scale
timeFrame: base line and 90 posoperative days
measure: Visual Analogue Scale - Satisfaction with aesthetic aspect of the nose
timeFrame: base line and 90 posoperative days
measure: Intensity of nasal obstruction
timeFrame: base line and 90 posoperative days
measure: NOSE Scale
timeFrame: base line and 90 posoperative days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Porto Alegre Clinicas Hospital ( HCPA)
name: Michelle Lavinsky, PHD
role: PRINCIPAL_INVESTIGATOR
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