NCT03854279Unknown4 期
Bizact Versus Electroscissor for Adult Tonsillectomy
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative pain: Number of days With need of analgesics
研究概览
简要总结
In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned elective tonsillectomy
- •informed consent
排除标准
- •regular use of analgesics pre-operatively
- •known tendency of bleeding
- •not able to communicate in Norwegian
研究组 & 干预措施
Electro-scissor
Active Comparator
Tonsillectomy will be done With electro-scissors
干预措施: tonsillar dissection (Device)
Bizact
Experimental
Tonsillectomy will be done With the Bizact device
干预措施: tonsillar dissection (Device)
结局指标
主要结局
Postoperative pain: Number of days With need of analgesics
时间窗: 2 weeks
Number of days With need of analgesics
次要结局
- Postoperative bleeding(2 weeks)
- Duration of surgery(0 - 1 hr)
- Postoperative pain: Dose need of pain killers during first 24 hr postoperatively(24 hrs)
- Per-operative bleeding(per-operative)
研究者
Johan C Ræder
Professor
Oslo University Hospital
研究点 (2)
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