Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
试验速览
- 阶段
- 不适用
- 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
- 否
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
干预措施: Unilateral Cleft Lip Repair: Millard 2 Technique (Procedure)
Unilateral Cleft Lip Repair with the New Hybrid Technique
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
Marco Kesting
Prof. Dr. med. Dr. med. dent.
University Hospital Erlangen
