Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 634
- 主要终点
- Number of retrieved central lymph nodes
研究概览
简要总结
Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
详细描述
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
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 (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor)
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
- •Age ≥ 18 years;
- •The pathological type is papillary thyroid carcinoma;
- •Tumor diameter <2 cm；
- •No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
- •cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
- •no obvious contraindication for thyroidectomy ;
- •Good comply with the research visit plan and other program requirements;
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
- •previous history of neck surgery, radiotherapy or thermal ablation;
- •hyperthyroidism and substernal goiter;
- •dedifferentiated thyroid carcinoma；
- •accompanied with severe thyroiditis.
结局指标
主要结局
Number of retrieved central lymph nodes
时间窗: 1 month after operation
The number of central lymph nodes removed during the operation
次要结局
未报告次要终点
研究者
Minghua Ge
PH.D
Zhejiang Provincial People's Hospital