NCT05206799Unknown不适用
A Multi-centre Clinical Study of Hemorrhage Rate After Coblation Tonsillectomy in Children
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- hemorrhage rate after coblation tonsillectomy
研究概览
简要总结
To obtain hemorrhage rate after coblation tonsillectomy, and to investigate risk factors of hemorrhage after coblation tonsillectomy in children.
详细描述
This study is a prospective and multi-centre trail in China. It intends to enroll 25000 patients underwent coblation tonsillectomy in 22 clinical centers in China. Hemorrhage rate and risk factors of hemorrhage after coblation tonsillectomy will be investigated through questionnaires.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •under 18 years old;
- •Clear indications for tonsill surgery;
- •No clear contraindications for tonsill surgery;
- •Parents of the children patients accept surgical treatment;
- •Parents of the children patients able to cooperate with the visit and follow-up.
排除标准
- •Children patients with a history of adenoid or tonsillectomy surgery;
- •Associated with refractory bleeding diseases;
- •Combined with cleft palate;
- •Down syndrome, Prader-Willi syndrome (PWS) or other chromosomal abnormalities;
- •Neuromuscular diseases (including cerebral palsy);
- •Other diseases that affect physical health, such as severe heart disease, kidney disease, lung disease, etc;
- •Contraindications to surgery and anesthesia;
- •Unable to obtain informed consent.
结局指标
主要结局
hemorrhage rate after coblation tonsillectomy
时间窗: 3 weeks after surgery
hemorrhage rate after coblation tonsillectomy in children within 3 weeks
risk factors of hemorrhage after coblation tonsillectomy
时间窗: 3 weeks after surgery
risk factors of hemorrhage after coblation tonsillectomy in children
次要结局
未报告次要终点
研究者
研究点 (1)
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