Lateral Crural Steal With Columellar Strut Graft in Primary Open Rhinoplasty

Официальное название

The Effect of Lateral Crural Steal With Columellar Strut Graft on Nasal Tip Projection and Rotation in Primary Open Rhinoplasty

Обзор

The goal of this clinical trial is to assess the effect of Lateral crural steal with Columellar strut graft done in Primary Open Rhinoplasty and its long-term sustainability on nasal tip projection and nasal tip rotation.

Подробное описание

Rhinoplasty is one of the most commonly performed aesthetic procedures worldwide, with the nasal tip being the most challenging aspect of it. The nasal tip represents the most anterior projecting point of the nose and is formed by the junction of the medial and lateral crura of lower lateral cartilages.

Projection, rotation, and definition are key aspects to be controlled and achieved in the nasal tip surgery. Preservation of natural tip support is a fundamental requirement of a successful rhinoplasty.

Although excisional techniques can produce reductions in lobular width, long-term contour alterations are unpredictable and subject to stigmatic tip deformity. As a consequence, aggressive excision-based techniques are increasingly recognized as haphazard, unpredictable, and disproportionately prone to undesirable postoperative contour deformities.

The lateral crural steal (LCS) is a tissue-conservative technique of nasal tip refinement through relocation of domal apices. Hence, modifying nasal tip projection and rotation. However, the long-term stability of tip position with LCS alone can be variable. To enhance support and long-term maintenance of tip projection, a columellar strut graft -placed between the medial crura- acts as a central scaffold, unifying the nasal tip and helping to control the final nasal tip position.

The lateral crural steal technique alone can achieve improvements in nasal tip projection and rotation, but with weak medial crura, it can twist or compress down the medial crura, which will result in loss of tip height. So, in the technique being studied, combining the LCS with a columellar strut graft can provide both dynamic and static support to the nasal tip.

Вмешательства

• Процедура Lateral crural steal with columellar strut graft in Primary Open Rhinoplasty
  Patients undergo primary open rhinoplasty under general anesthesia. After local infiltration, an open approach is performed using an inverted-V transcolumellar incision with bilateral marginal incisions. The skin-soft tissue envelope is elevated in the supra-perichondrial plane. Dorsal deformities are corrected and septoplasty is performed with cartilage harvest. Vestibular skin is undermined and cephalic trimming of the lateral crura is carried out. Lateral crural steal is performed by advancin

Первичные конечные точки

• Nasal tip projection. [Срок оценки: Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.]
• Nasal tip rotation [Срок оценки: Analysis will be done preoperatively, immediate postoperatively, and at 6-month and 1-year postoperatively.]

Вторичные конечные точки (1)

• Patient's satisfaction [Срок оценки: The questionnaire will be conducted pre-operatively (as a baseline), 3-month and 1-year postoperatively.]

Критерии участия

Критерии включения

• Patients seeking primary rhinoplasty for aesthetic and/or functional indications.
• Presence of inadequate nasal tip projection and/or rotation suitable for correction using lateral crural steal with columellar strut graft.
• Ability to provide written informed consent and comply with follow-up visits.

Критерии исключения

• History of prior nasal surgery.
• History of severe nasal trauma, altering cartilage architecture.
• Significant functional nasal obstruction requiring complex external nasal valve reconstruction.
• Patients with excessively wide alar base requiring alar base reduction involving vestibular sill excision (to prevent confounding on projection/rotation).
• Patients with facial skeletal or developmental abnormalities e.g. maxillary hypoplasia, maxillary prognathism, dentofacial deformities.
• Patients with psychiatric illness or Body Dysmorphic Disorder.
• Significant medical comorbidities contraindicating elective surgery or general anesthesia.
• Inability to provide informed consent or comply with follow-up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Kafrelsheikh University Hospital — Kafr ash Shaykh

Публикации

• Mulafikh DS, Alharethy SE, Alqabbani AA, Mesallam TA. Validation and clinical application of the Arabic rhinoplasty outcomes evaluation questionnaire. Saudi Med J. 2021 Jun;42(6):655-659. doi: 10.15537/smj.2021.42.6.20210038. PMID 34078728
• Alsarraf R. Outcomes research in facial plastic surgery: a review and new directions. Aesthetic Plast Surg. 2000 May-Jun;24(3):192-7. doi: 10.1007/s002660010031. PMID 10890946
• Apaydin F, Akyildiz S, Hecht DA, Toriumi DM. Rhinobase: a comprehensive database, facial analysis, and picture-archiving software for rhinoplasty. Arch Facial Plast Surg. 2009 May-Jun;11(3):209-11. doi: 10.1001/archfacial.2009.35. No abstract available. PMID 19451458
• Cetiner H. The Effect of Anchoring the Columellar Strut Graft to the Lateral Crural Steal Suture in Patients With a Low Nasal Tip: A New Technique. J Craniofac Surg. 2019 Mar/Apr;30(2):437-441. doi: 10.1097/SCS.0000000000005110. PMID 30614999
• Davis RE. Lateral crural tensioning for refinement of the wide and underprojected nasal tip: rethinking the lateral crural steal. Facial Plast Surg Clin North Am. 2015 Feb;23(1):23-53. doi: 10.1016/j.fsc.2014.09.003. PMID 25430927
• Kridel RW, Konior RJ, Shumrick KA, Wright WK. Advances in nasal tip surgery. The lateral crural steal. Arch Otolaryngol Head Neck Surg. 1989 Oct;115(10):1206-12. doi: 10.1001/archotol.1989.01860340060018. PMID 2789776
• Sepehr A, Alexander AJ, Chauhan N, Chan H, Adamson PA. Cephalic positioning of the lateral crura: implications for nasal tip-plasty. Arch Facial Plast Surg. 2010 Nov-Dec;12(6):379-84. doi: 10.1001/archfacial.2010.87. PMID 21079114
• Toriumi DM. New concepts in nasal tip contouring. Arch Facial Plast Surg. 2006 May-Jun;8(3):156-85. doi: 10.1001/archfaci.8.3.156. PMID 16702528

Идентификаторы

NCT: NCT07317947 · KFSIRB200-725

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗