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临床试验/NCT03282721
NCT03282721已完成不适用

Transverse Facial Cleft (Macrostomia) Repair: Modification of a Traditional Technique

Peking Union Medical College Hospital0 个研究点目标入组 9 人开始时间: 2012年1月1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
9
主要终点
symmetry of the commissures

研究概览

简要总结

To compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

详细描述

Nine patients with transverse facial cleft were treated with redesigned repair using precise location of commissure. The main outcome measurement included scar, symmetry of the commissure. They were graded in five scores by five resident physicians who had never seen the patients. The results were compared with healthy controls.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
3 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of transverse facial cleft disease;
  • Must not received any lip surgeries before;
  • Such disease can be accompanied by external ear abnormalities, hypoplastic mandible, cleft lip and palate.

排除标准

  • Severe general diseases;
  • Patients who had been treated with lip surgery;
  • Patients and/or his/her family didn't want to continue the clinical trial.

结局指标

主要结局

symmetry of the commissures

时间窗: 6 to 12 months after surgery

symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.

Scar of the repaired commissures

时间窗: 6 to 12 months after surgery

scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.

次要结局

  • symmetry of the commissures(1 to 6 months after surgery)
  • scar of the repaired commissures(1 to 6 months after surgery)

研究者

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

Lian Zhou

Prof.

Peking Union Medical College Hospital

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