Bizact Tonsillectomy in Adults - Randomized Study Assigning Postoperative Pain, Bleeding and Cost-effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14
研究概览
简要总结
Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage)
详细描述
Bizact is an electrosurgical instrument developed for tonsillectomy. Bizact causes less thermal damage to tissues than traditional bipolar coagulation, and thus is assumed, that using Bizact might lead to faster and less painful recovery. Furthermore, incidence of postoperative hemorrhage is assumed to be lower.
The study evaluates the usability of Bizact and it's impact on postoperative pain, the occurrence of secondary postoperative hemorrhage, and the total costs of surgery compared with traditional bipolar tonsillectomy.
We recruit 225 patients who are randomized into three groups.
- both tonsils are removed with Bizact
- both tonsils are removed with traditional method using bipolar cautery and scissors
- one tonsil is removed with Bizact ant the other with bipolar cautery and scissors Patients are blinded with respect to group. Postoperative recovery is monitored on a daily basis with a questionnaire.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tonsillectomy due to chronic tonsillitis or tonsillar hypertrophy
- •Age ≥18 years
排除标准
- •Unilateral tonsillectomy
- •History of peritonsillar abscess
- •Coagulation disorder or ongoing anticoagulation therapy
- •Re-tonsillectomy
- •Additional simultaneous procedure
研究组 & 干预措施
Bizact tonsillectomy
Patients operated with Bizact® instrument
干预措施: Tonsillectomy (Device)
Conventional tonsillectomy
Patient operated with conventional technique (bipolar cautery and scissors)
干预措施: Tonsillectomy (Device)
Bizact-Conventional
Side-controlled group, in which one tonsil is operated with Bizact® and another with conventional technique (bipolar cautery and scissors)
干预措施: Tonsillectomy (Device)
结局指标
主要结局
Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14
时间窗: within 2 weeks after surgery
Patients receive a questionnaire to assess their recovery during the first 14 postoperative days. Pain is evaluated separately for each side every morning before taking any analgesics and reported using a numeric rating scale 0-10.
次要结局
- Usage of pain medication(14 days postoperatively)
- Incidence of primary hemorrhage(24 hours postoperatively)
- Incidence of secondary hemorrhage(from 24 hours to 14 days postoperatively)
研究者
Johanna Ruohoalho
MD, PhD
Helsinki University Central Hospital