Robotic Surgery Via Bilateral Axillo-breast Approach for Relatively Low-risk Papillary Thyroid Carcinoma With Lateral Cervical Lymph Node Metastasis: a Safe and Effective Cosmetic Procedure in the Context of Prevalent Thyroid Ultrasound Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Number of retrieved Lymph nodes
研究概览
简要总结
The goal of this observational study is to learn the efficacy, cosmetic effectiveness and safety of robotic modified radical neck dissection in well-selected cases, through direct comparison with conventional open surgery in low-risk papillary thyroid carcinoma with lateral cervical lymph node metastasis. The main questions it aims to answer are:
Does robotic neck dissection provide tumor clearance equivalent to that of the conventional open approach? How does the postoperative complication rate of the robotic technique compare with open surgery? Are patients satisfied with the cosmetic appearance of the wound following robotic neck dissection? Researchers will compare robotic surgery with conventional open surgery to see if it has the same efficacy, cosmetic effectiveness and safety.
Participants' postoperative recovery will be followed up, and they will provide pain scores and rate their cosmetic satisfaction with the wound.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •(1) PTC with lateral LN metastasis confirmed by fine needle aspiration (FNA) biopsy;
- •(2) maximum tumor size < 3 cm;
- •(3) without extrathyroidal extension;
- •(4) metastatic LNs in unilateral levels II, III, IV and/or V;
- •(5) number of suspicious metastatic LNs based on preoperative ultrasonography < 5;
- •(6) maximum metastatic LN diameter < 3 cm.
排除标准
- •(1) metastatic LNs in level I or VII;
- •(2) metastatic LNs fused with each other or fixed in the neck or extra-nodal extension;
- •(3) history of neck surgery or radiation therapy;
- •(4) extranodal extension;
- •(5) the presence of TERT mutation.
结局指标
主要结局
Number of retrieved Lymph nodes
时间窗: From enrollment to the end of surgical procedure
postoperative complications
时间窗: From enrollment to the end of treatment at 1 year
Vocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage
次要结局
未报告次要终点