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Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty

Primary Purpose

Rhinoplasty, Surgical Procedure, Unspecified, Surgery, Plastic

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Alar facial groove incision
Alar facial groove spared
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoplasty focused on measuring alar base reduction, alar facial groove, alectomy, Flare, Nose

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alar facial groove Incision

Alar facial groove spared

Arm Description

Alar Base surgical modification with surgical inions in the alar facial groove

Alar Base surgical modification with surgical incisions 1mm above the alar facial groove

Outcomes

Primary Outcome Measures

Stony Brook Scar Evaluation Scale (SBSES)
Patients will be evaluated personally by blinded examiners who will graduate the scars according to the standardized Stony Brook scoring evaluation scar which has a minimum score of 0 and a maximum score of 5 points according to 5 characteristics of the scar ( width, height, color, hatch/suture mark, overall appearance)

Secondary Outcome Measures

Rhinoplasty Outcome Evaluation (ROE) Scale
The Rhinoplasty Outcome Evaluation (ROE) scale is an easy-to-use questionnaire, designed for the evaluation of rhinoplasty results. This instrument is composed of six questions that assess three domains of quality of life: physical, mental / emotional and social. Each question is scored on a scale of 0 to 4 and converted to a total score of 0 to 100, dividing the value by 24 and multiplying by 100. A score above 85 is considered excellent and generally means that the patient is very satisfied. However, the comparison of pre and postoperative values usually provide the most relevant information. Patients will be asked to respond to this scale in the base line and at 90 postoperative days.
Visual Analogue Scale - Satisfaction with aesthetic aspect of the nose
Patients will be asked to complete an analogue-visual scale (Annex 3) indicating the degree of satisfaction with the appearance of their nose. This scale will be converted into a scale ranging from 0 to 10, and the value 10 represents the highest satisfaction level possible. The scale will be applied in the base line as well as in the 90 postoperative days.
Intensity of nasal obstruction
Patients will be asked to complete an analogue-visual scale indicating the severity of their nasal obstruction that will be converted from 0 to 10, and the value 10 represents symptoms of nasal obstruction of greater intensity. The scale will be applied at the base line, as well as at the 90 postoperative days.
NOSE Scale
The NOSE (Nasal Obstruction Symptom Evaluation Scale) scale will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at 90 postoperative days.

Full Information

First Posted
June 28, 2017
Last Updated
July 7, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03213548
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Anticipated)
Primary Completion Date
September 15, 2019 (Anticipated)
Study Completion Date
September 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoplasty, Surgical Procedure, Unspecified, Surgery, Plastic, Cicatrix, Healing Scar
Keywords
alar base reduction, alar facial groove, alectomy, Flare, Nose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alar facial groove Incision
Arm Type
Experimental
Arm Description
Alar Base surgical modification with surgical inions in the alar facial groove
Arm Title
Alar facial groove spared
Arm Type
Active Comparator
Arm Description
Alar Base surgical modification with surgical incisions 1mm above the alar facial groove
Intervention Type
Procedure
Intervention Name(s)
Alar facial groove incision
Intervention Description
All procedures related to alterations in the alar base will be based on an algorithm proposed by 2010 Adamnson et al lar Soft-Tissue Techniques in Rhinoplasty Algorithmic Approach, Quantifiable Guidelines, and Scar Outcomes From a Single Surgeon Experience ,published at Archives Facial Plastic Surgery in which a sequential approach is used, evaluating step-by-step surgical needs. Initially, the alar base can be reduced by removing tissue from the nasal sill. At this step, modifications at the shape or the width of the nostrils can be done. After that, a rotation-advancement flap is made, and the sill defect is closed. The nasal flair is then assessed and tissue from the alar border can be removed if needed. The incisions not spare the alar facial groove.
Intervention Type
Procedure
Intervention Name(s)
Alar facial groove spared
Intervention Description
The technique is the same of the Alar facial groove incision intervention group, but the incisions spare the groove. The incisions will be at 1 mm above the groove.
Primary Outcome Measure Information:
Title
Stony Brook Scar Evaluation Scale (SBSES)
Description
Patients will be evaluated personally by blinded examiners who will graduate the scars according to the standardized Stony Brook scoring evaluation scar which has a minimum score of 0 and a maximum score of 5 points according to 5 characteristics of the scar ( width, height, color, hatch/suture mark, overall appearance)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Rhinoplasty Outcome Evaluation (ROE) Scale
Description
The Rhinoplasty Outcome Evaluation (ROE) scale is an easy-to-use questionnaire, designed for the evaluation of rhinoplasty results. This instrument is composed of six questions that assess three domains of quality of life: physical, mental / emotional and social. Each question is scored on a scale of 0 to 4 and converted to a total score of 0 to 100, dividing the value by 24 and multiplying by 100. A score above 85 is considered excellent and generally means that the patient is very satisfied. However, the comparison of pre and postoperative values usually provide the most relevant information. Patients will be asked to respond to this scale in the base line and at 90 postoperative days.
Time Frame
base line and 90 posoperative days
Title
Visual Analogue Scale - Satisfaction with aesthetic aspect of the nose
Description
Patients will be asked to complete an analogue-visual scale (Annex 3) indicating the degree of satisfaction with the appearance of their nose. This scale will be converted into a scale ranging from 0 to 10, and the value 10 represents the highest satisfaction level possible. The scale will be applied in the base line as well as in the 90 postoperative days.
Time Frame
base line and 90 posoperative days
Title
Intensity of nasal obstruction
Description
Patients will be asked to complete an analogue-visual scale indicating the severity of their nasal obstruction that will be converted from 0 to 10, and the value 10 represents symptoms of nasal obstruction of greater intensity. The scale will be applied at the base line, as well as at the 90 postoperative days.
Time Frame
base line and 90 posoperative days
Title
NOSE Scale
Description
The NOSE (Nasal Obstruction Symptom Evaluation Scale) scale will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at 90 postoperative days.
Time Frame
base line and 90 posoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
João Pedro Garcia, MD
Phone
+5551996154290
Email
jptg@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
João Pedro Garcia, MD
Phone
+55996154290
Email
jptg@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Lavinsky, PHD
Organizational Affiliation
Porto Alegre Clinicas Hospital ( HCPA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Pedro Garcia, MD
Phone
+55996154290
Email
jptg@terra.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21788798
Citation
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Results Reference
background
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15781717
Citation
Kridel RW, Castellano RD. A simplified approach to alar base reduction: a review of 124 patients over 20 years. Arch Facial Plast Surg. 2005 Mar-Apr;7(2):81-93. doi: 10.1001/archfaci.7.2.81.
Results Reference
background
PubMed Identifier
20479430
Citation
Warner JP, Chauhan N, Adamson PA. Alar soft-tissue techniques in rhinoplasty: algorithmic approach, quantifiable guidelines, and scar outcomes from a single surgeon experience. Arch Facial Plast Surg. 2010 May-Jun;12(3):149-58. doi: 10.1001/archfacial.2010.30.
Results Reference
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15781718
Citation
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3068968
Citation
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Results Reference
result

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Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty

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