Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)
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
- 否
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
Benito Benitez
Principal Investigator
University Hospital, Basel, Switzerland
