跳至主要内容
临床试验/NCT05102513
NCT05102513Unknown不适用

Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Marco Kesting2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
Marco Kesting
入组人数
20
试验地点
2
主要终点
Measurement of the length of the philtral colomn on the cleft and non-cleft side

研究概览

简要总结

Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening.

However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.

研究设计

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

入排标准

年龄范围
2 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Complete unilateral cleft lip and palate

排除标准

  • 未提供

研究组 & 干预措施

Unilateral Cleft Lip Repair with the Millard II Technique

Active Comparator

干预措施: Unilateral Cleft Lip Repair: Millard 2 Technique (Procedure)

Unilateral Cleft Lip Repair with the New Hybrid Technique

Experimental

干预措施: Unilateral Cleft Lip Repair: Hybrid Technique (Procedure)

结局指标

主要结局

Measurement of the length of the philtral colomn on the cleft and non-cleft side

时间窗: perioperatively to 6 month postoperatively

Perioperatively, a 3-D scan and photos are taken. Additional photos are also taken after the removal of the stitches, after 3 months and after 6 months. From these, the increase in length of the philtral column can be determined with 3D computer software and with a linear measurement of the photos.

Distance from the midpoint of the columella to the lateral alae

时间窗: perioperatively

Perioperatively, a 3-D scan and photos are taken. The distance can be measured with a 3D computer software and with a linear measurement of the photos.

Angle of the columella

时间窗: perioperatively

A 3d scan and photos are made perioperatively. From this the angle of the columella can be determined with a 3D Computer software and with a linear measurement of the photos.

次要结局

未报告次要终点

研究者

发起方
Marco Kesting
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marco Kesting

Prof. Dr. med. Dr. med. dent.

University Hospital Erlangen

研究点 (2)

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