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临床试验/NCT03683199
NCT03683199已完成不适用

Objective Assessment for Cleft Lip Nasal Deformity Correction

Assiut University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
2
主要终点
Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction)

研究概览

简要总结

Rhinoplasty remains one of the most challenging procedures in plastic surgery, and patients with cleft lip nasal deformity pose an even greater challenge, in which biggest issue is to achieve caudal nose harmony and creation of symmetrical nostrils with patent normal nasal function

详细描述

Cleft lip and palate represent the most common birth defects affecting the head and neck region. It has been estimated, based on global birth rates that a child born with a cleft every 2.5 minutes .which is associated with varying degrees of nasal deformity grading from mild to severe inadequate function, shape and appearance of the nose. Functional impairment of the nose has been reported in 70% of cases with cleft lip. It negatively affects patients' personal and professional lives, physical activity, well-being and general quality of life.

However, historical interest in cleft lip and palate was traced to pre-Columbian artisan; the interest in the associated nasal deformities only began with rhinoplasty techniques introduced in the 19th century. That's why despite the great improvement achieved in primary repair of cleft lip and nasal deformity, the secondary cleft and nasal deformity still occur in significant number of patients, and the surgical management of the nasal deformity remains a functional and aesthetic dilemma for patients, their families and for reconstructive surgeons.

Lake of objective assessment of the initial severity and the changes introduced by growth and by surgical treatment lead to inability to optimize a treatment of cleft lip nasal deformity, hence there is no perfect surgical technique exists and surgeons must tailor approaches to individuals and evolve techniques to best serve each patient.

Although surgery can give dramatic effect, the lack of objective assessment of different surgical procedures results in decision that is based on the experience of the surgeon.

Secondary rhinoplasty is done after facial growth is completed. This is around 14 to 16 years old in female patients and 16 to 18 years old in male patients. Surgical techniques rely on well-accepted open rhinoplasty principles and are applied for unilateral or bilateral cleft nasal deformities.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age group: > 14-16 years old females and >16-18 years old male patients.
  • Patients with unilateral or bilateral cleft lip nasal deformity that isn't previously operated.

排除标准

  • Previous rhinoplasty operated CLND cases.
  • Patients who need skeletal base reconstruction.
  • Syndromic cases.
  • Post traumatic nasal deformity.
  • Female patients less than 14 years' old and male patients less than 16 years old.

结局指标

主要结局

Objective Assessment for cleft lip nasal deformity correction using MSCT with 3Dimentions in flesh mode (to compare some nasal lengths in millimeters before and after correction)

时间窗: three years

we will use Multislice CT 3D flesh mode to compare the columellar length in millimeters and inter-alar dimensions in millimeters before and after the surgical correction

次要结局

  • Patient's subjective assessment pre and post-operative using Rhinoplasty Outcome Evaluation questionnaire(three years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hafsa Gamal Muhammad bakheet

Assistant teacher

Assiut University

研究点 (2)

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