Surgical Procedure, Unspecified Clinical Trial
Official title:
Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty : A Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 15, 2020 |
Est. primary completion date | September 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Bennett GH, Lessow A, Song P, Constantinides M. The long-term effects of alar base reduction. Arch Facial Plast Surg. 2005 Mar-Apr;7(2):94-7. — View Citation
Boyette JR, Stucker FJ. African American rhinoplasty. Facial Plast Surg Clin North Am. 2014 Aug;22(3):379-93. doi: 10.1016/j.fsc.2014.04.004. Review. — View Citation
Foda HM. Nasal base narrowing: the combined alar base excision technique. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):30-4. — View Citation
Hagan KF. Clinical photography for the plastic surgery practice--the basics. Plast Surg Nurs. 2008 Oct-Dec;28(4):188-92; 193-4. doi: 10.1097/01.PSN.0000342822.44387.c5. — View 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. — View Citation
Lima LF, Arroyo HH, Jurado JR. Update in alar base reduction in rhinoplasty. Curr Opin Otolaryngol Head Neck Surg. 2016 Aug;24(4):316-21. doi: 10.1097/MOO.0000000000000277. — View Citation
Patel AD, Kridel RW. African-American rhinoplasty. Facial Plast Surg. 2010 May;26(2):131-41. doi: 10.1055/s-0030-1253499. Epub 2010 May 4. — View Citation
Porter JP. The average African American male face: an anthropometric analysis. Arch Facial Plast Surg. 2004 Mar-Apr;6(2):78-81. — View Citation
Rohrich RJ, Ahmad J. Rhinoplasty. Plast Reconstr Surg. 2011 Aug;128(2):49e-73e. doi: 10.1097/PRS.0b013e31821e7191. Review. — View Citation
Stucker FJ, Lian T, Sanders K. African American rhinoplasty. Facial Plast Surg Clin North Am. 2005 Feb;13(1):65-72. Review. — View Citation
Swamy RS, Sykes JM, Most SP. Principles of photography in rhinoplasty for the digital photographer. Clin Plast Surg. 2010 Apr;37(2):213-21. doi: 10.1016/j.cps.2009.12.003. — View Citation
Tardy ME Jr, Patt BS, Walter MA. Alar reduction and sculpture: anatomic concepts. Facial Plast Surg. 1993 Oct;9(4):295-305. — View 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. — View Citation
Weir RF. On restoring sunken noses without scarring the face. 1892. Aesthetic Plast Surg. 1988 Nov;12(4):203-6. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 90 days | |
Secondary | 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. | base line and 90 posoperative days | |
Secondary | 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. | base line and 90 posoperative days | |
Secondary | 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. | base line and 90 posoperative days | |
Secondary | 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. |
base line and 90 posoperative days |
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