Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.
研究概览
简要总结
Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.
the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.
详细描述
Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.
the goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.
In the study three approaches are prospectively compared:
- Tonsillectomy - using electrocautery resecting all tonsillar tissue.
- Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.
- laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser.
All patients will be randomized to one of three arms. Each arm will include 25 children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids
排除标准
- •Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome
结局指标
主要结局
Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.
时间窗: 12 months
次要结局
- Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.(12 months)
研究者
Ben-Zion Joshua
MD
Soroka University Medical Center