Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
研究概览
简要总结
The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.
详细描述
A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 120 patients who required a thyroidectomy for thyroid benign disease, will be randomized to either Harmonic Focus or Ligasure small-Jaw or clamp-and-tie technique during thyroidectomy. The operative time (minutes), morbidity rate (%), post-operative blood loss (milliliters), hospital stay (days), post-operative hypocalcemia (%), and cost of thyroidectomy (euros) were compared between the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thyroid benign disease
排除标准
- •malignant disease
- •thyroid malign disease requiring lymphadenectomy
- •coagulatory disease
研究组 & 干预措施
Ligasure Small-JAW
干预措施: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus (Procedure)
Harmonic Focus
干预措施: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus (Procedure)
Clamp-and-Tie technique
干预措施: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus (Procedure)
结局指标
主要结局
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
次要结局
- Cost assessment of new generation devices in thyroid surgery
研究者
Giulia Cosenza
Principal Investigator
Ospedale Regina Apostolorum