A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Lateral cervical lymph node cleaning time
研究概览
简要总结
Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.
详细描述
To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;
- •patient's concerns of neck scars and cosmetic requirement.
排除标准
- •were as follows:
- •tumor size >4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve.
- •5）metastatic lymph nodes occurred below the sternoclavicular joint.
研究组 & 干预措施
Robot lateral neck lymph node dissection
Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.
干预措施: Robot (Device)
Total endoscopic lateral cervical lymph node dissection
Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.
干预措施: Total endoscopic (Device)
结局指标
主要结局
Lateral cervical lymph node cleaning time
时间窗: During surgery
Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen
Intraoperative internal jugular vein bleeding.
时间窗: 6 months after surgery
Internal carotid vein hemorrhage affect that surgical procedure
Accessory nerve injury
时间窗: During surgery
Accessory nerve injury
次要结局
- Number of participants with HypoParathyroidism(6 months after surgery)
- Recurrent laryngeal nerve injury.(6 months after surgery)
- The time of the thyroid gland removal(During surgery)
研究者
Bo Wang,MD
clinical professor
Fujian Medical University