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临床试验/NCT04616690
NCT04616690已完成不适用

Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age

研究概览

简要总结

This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • patients with orofacial cleft, who undergo routine cleft repair

排除标准

  • missing datasets
  • no signed consent for research

结局指标

主要结局

True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age

时间窗: Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.

True cleft area in mm2 will be measured at 8 month of age in newborns with cleft lip and palate.

次要结局

  • Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair(At 3 months postoperative)
  • Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair(At surgery and at 3 months postoperative)
  • Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age(Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benito Benitez

Principal Investigator

University Hospital, Basel, Switzerland

研究点 (1)

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