Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 280
- 试验地点
- 15
- 主要终点
- Postoperative complications
研究概览
简要总结
Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures.
Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications
详细描述
This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure. Adult patients with benign or malignant thyroid disease and normal function will be included. Patients with giant goiter, hyperthyroidism, non differentiated thyroid carcinoma, locally invasive tumors, neck dissection, previous neck radiotherapy or chemotherapy, video assisted surgery and severe comorbidities will be excluded. calculated sample size was 280 patients. Outcomes will be assessed by an independent monitor. All centers will made a previous standardization of surgical procedures.
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
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
- •Adult (>18 y/o)
- •Benign or malignant thyroid disease
- •Proposal of total thyroidectomy
- •Normal thyroid function
排除标准
- •Giant goiter
- •Hyperthyroidism
- •Non differentiated thyroid carcinoma
- •Locally invasive tumors
- •Neck dissection as a part of procedure
- •Previous surgery, radiotherapy or I131 therapy on neck
- •Video-assisted or endoscopic thyroidectomy
- •Severe comorbidities
- •Coagulation disorders
结局指标
主要结局
Postoperative complications
次要结局
- Operative time
- Drainage volume
- Postoperative pain
- Length of stay
- Direct Costs