NCT03877666已完成不适用
Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2020年8月4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
- 77
- 试验地点
- 1
- 主要终点
- Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured
研究概览
简要总结
Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.
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 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with orofacial clefts, who undergo routine cleft repair
排除标准
- •missing datasets
- •no signed consent for research.
研究组 & 干预措施
control group
cleft lip surgery only
medial incision only
Minimal incision group: palatoplasty using medial-only incisions
lateral incision
Lateral incision group: palatoplasty with lateral releasing incisions
结局指标
主要结局
Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured
时间窗: One measurement before surgery, one measurement immediately after surgery
The difference and impact of our routine surgical technique on the tissue perfusion of the palate is measured non-invasively with a probe (regional StO2%). Localized measurement of the microvascular hemoglobin oxygen saturation.
次要结局
- Status of wound healing(at 3 month and 6 month after surgery)
- Perioperative Complications(6 months)
研究者
研究点 (1)
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