BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- Operative time
研究概览
简要总结
The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.
详细描述
It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.
Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils.
With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.
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
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children scheduled for tonsillectomy at Alberta Children Hospital
- •Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.
排除标准
- •Craniofacial abnormalities
- •Bleeding disorders
- •Complex medical background
结局指标
主要结局
Operative time
时间窗: during the procedure
The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery
次要结局
- Intraoperative blood loss(during the procedure)