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临床试验/NCT05080855
NCT05080855已完成不适用

Unilateral Cleft Lip Repair: Quantitative (Anthropometric) Comparative Assessment of Modified Millard vs Tennison-Randall Techniques.

Cairo University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年6月5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
68
试验地点
2
主要终点
Assessment of Post-operative Complications

研究概览

简要总结

Over the past century, there have been major advances in unilateral cleft-lip repair techniques toward the method's modern form. The first documented cleft-lip repair involved simple freshening and approximation of the cut cleft edges, followed by the use of curved incisions to allow lengthening of the lip. Straight-line closure repairs were used in the early 1900; however, straight-line closures had the disadvantage of creating a vertical scar contracture, leading to notching of the lip. This led to the development of several methods in the mid-twentieth century that are grouped as quadrangular flaps, triangular flaps, and rotation-advancement techniques.

The two basic techniques that are most commonly used for unilateral cleft lip (UCL) closure are the Tennison-Randall and the Millard rotation_advancement techniques. both techniques address the importance of repositioning the lip muscle (orbicularis oris) in the correct anatomic orientation for optimal aesthetic and functional outcomes.

The ultimate goal of cleft lip surgery is to achieve a perfectly symmetrical lip and nose. It has been shown that for the general population, the more symmetrical the face, the more attractive the face is. The appearance and symmetry of the nasolabial region is also seen as one of the most important characteristics when evaluating the results of any facial surgery.

Measurement of treatment outcome is vital to evaluate the success of cleft management and the degree of improvement, especially in the present age of evidence-based medicine where treatment guidelines for best practice are becoming an integral part of contemporary clinical practice.

The good goal of cleft lip repair is a symmetrical and balanced lip with minimal scar restoring the natural contours of the face, as well as correcting functional anatomy.

Objectives To evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison_ Randall technique in unilateral cleft lip (ucl) repair.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patient with age from 2 months old to 6 months old.
  • Patient with unilateral cleft lip complete or incomplete type.

排除标准

  • Patient with age less than 2 months old or more than 6 months old.
  • Patients with bilateral cleft lip
  • Patients with recurrent cleft lip.
  • Patients with associated major congenital anomalies like major cardiac anomalies.

结局指标

主要结局

Assessment of Post-operative Complications

时间窗: 1 month

Early: Wound infection. Wound dehiscence. Late: Wound scarring. Lip notch

次要结局

  • Operative time(intraoperatively)
  • Anthropometry assessment of Cosmetic Results(patients were assessed before the operation and followed for 3-4 weeks after.)
  • Satisfaction score(24 hours after the operation)

研究者

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

Khaled Salah Ahmed

Faculty of Pediatric Surgery

Cairo University

研究点 (2)

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