The Efficacy and Safety of Thunderbeat in Thyroid Surgery: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
研究概览
简要总结
The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.
详细描述
Thunderbeat instrument combines an advanced bipolar clamp to the existing ultrasonic cutter. In the animal study with pig, the result of Thunderbeat shows fast abalation rate and same thermal conductivity. There has been reported a significant reduction in operative time and same complications with Thunderbeat in gynecology patient who underwent laparoscopic hysterectomy with lymph node dissection. Comparison of the utilization of this new device, however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The objective of this study is to compare the results of thyroidectomy using the Thunderbeat to that with the Harmonic scalpel device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery department are randomized into those operated with Thunderbeat (Group A) and those with Harmonic scalpel (Group B).
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •thyroidectomy
- •normal vocal cord
排除标准
- •additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
- •Thyroid cancer patients with lymph node metastasis
- •pregnant women
- •uncontrolled hypertension, DM, chronic kidney failure, coagulation disorders
- •aspirin or anti-platelet agent in 7 days
- •Graves' disease or Hashimoto thyroiditis
- •history of radiation treatment in head and neck area
结局指标
主要结局
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
时间窗: postoperatively (from the day of surgery until 3 months postoperatively)
次要结局
- Hemostasis(intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 2 day postoperatively))
- Operative time(from skin incision to skin closure)
研究者
Su-jin Kim
Clinical Assistant Professor
Seoul National University Hospital