跳至主要内容
临床试验/NCT03891719
NCT03891719Unknown不适用

Correction of the Unilateral Cleft Lip Nasal Deformity Using Sliding Chondrocutaneous Flap, Caudal Septal Extension Graft and Auricular Cartilage Graft

University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
35
试验地点
2
主要终点
Assessment of ratio of the nose in harmony with the face after secondary unilateral cleft lip rhinoplasty

研究概览

简要总结

Cleft lip and cleft palate are the most common birth defects of craniofacial development. The surgical repair of this deformity requires comprehensive management plans and well cooperating interdisciplinary cleft teams. Secondary cleft rhinoplasty remains one of the most challenging procedures and aims for restoring nostril symmetry, enhancing nasal function, and improvement of aesthetic outcomes.

详细描述

For the majority of cleft patients, surgeons usually delay secondary rhinoplasty to ages 14 to 16 years for females and 16 to 18 years for males until after completion of nasal growth Unilateral secondary cleft nasal deformity results from hypoplastic nasal tissue, asymmetric growth due to impaired growth, and surgical scarring. The most common deformities include caudal septal deviation, retrodisplacement and under-projection of dome, lateral slumping of the medial crus of the lower lateral cartilage, alar-columellar web, insufficiency of vestibular skin and deficiency of nasal floor. Moreover, these deformities have negative effect on human well-being and quality of life.

Despite the opinions on how to address the problems, it seems clear that repositioning and reshaping of the cleft-side cartilages is necessary for restoring form and function. In general, in order to there are two basic approaches: those techniques that move the cleft-side lower lateral cartilage from medial to lateral, and those that move the lower lateral cartilage from lateral to medial. In an effort to correct the vestibular lining deficiency, easily be adapted to combine Tajima's reverse-U incisions for treatment of alar hooding, need for other structural grafts, sliding chondrocutaneous flap offers many advantages. However, in order to improve nasal tip position or columella shape through modification of either the anterior septal and/or posterior septal angle position and to act as the fundamental attachment for sliding lower lateral cartilage, Caudal septal extension and Columellar strut graft play an important role to stabilize the nasal tip.

Besides, with the aim of making it harmonize better with other facial features, dorsal augmentation is needed for improving the shape of the nose. Selecting the optimal material continues to be a challenge. For most surgeons, an autogenous cartilage graft is the first choice in rhinoplasty because of its resistance to infection and resorption.

We assess the functional and aesthetic outcomes based on three criteria:

  1. Change in nose symmetry and nasal height (Preoperative and postoperative photographic analyses)
  2. Change in functional outcomes through subjective and objective measurement (Questionaire and acoustic rhinometry)
  3. Change in Quality of life (Rhinoplasty Outcome Evaluation Questionaire)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral cleft lip deformity that was previously performed primary cheiloplasty
  • No other craniofacial malformation
  • Age: > 14-16 years old in female, >16-18 years old in male
  • Patients with follow-up period of at least 6 months.

排除标准

  • Patients who were suffered infection of facial structure

结局指标

主要结局

Assessment of ratio of the nose in harmony with the face after secondary unilateral cleft lip rhinoplasty

时间窗: Three years

Measure the angles and ratios of the nose and its relation to the face (nasal projection and length, Goodle ratio, nasolabial angle)

Assessment of nose symmetry after secondary unilateral cleft lip rhinoplasty

时间窗: Three years

Use computer software program to compare the nostril symmetry preoperatively and postoperatively: columella height (mm), columella width (mm), nostril height (mm), nostril width (mm), nose base (mm)

次要结局

  • Subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (ROE)(Three years)
  • Objective assessment of functional outcomes(Three years)

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chuong Dinh Nguyen, MD

Principle Investigator

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

Loading locations...

相似试验