Coblation Versus Cold Adenoidectomy -Safety and Efficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- safety (bleeding , dehydration or any other complications)
研究概览
简要总结
Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.
详细描述
Obstructive sleep apnea(osa) in children is a very bother and frequent problem with clinical and behavioral impacts. The hypertrophied adenoid tissue obstructs the air way in the nasopharynx that initiates the common symptoms. The treatment from that concerning problems is in the operation rooms by diversity surgical methods, the very older one is the cold dissection adenoidectomy.
Recently many surgeons use the coblation system as a preferred method for adenoidectomy. This method was proof as a safe and efficient especially referring to the bleeding and the dehydration risk .
Many children that operated by the cold dissection forced to perform another one or two operations presumably due to the adenoid tissue that did not removed completely from the first operation .
our hypothesis is that the coblation systemis a safe and eficient method for adenoidectomy.
The aims of this project is to verify if our theory is corect by blinded comparision between two methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children with obstructive symptoms
- •the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)
排除标准
- •without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.
- •tonsillectomy
- •Non randomalization, not blinded
结局指标
主要结局
safety (bleeding , dehydration or any other complications)
时间窗: percent of bleeding and dehydration
measure the event of bleeding , dehydration or any other complications
次要结局
- efficacy (pain post operation by scales evaluation)(pain and examination for residual adenoid tissue)