The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The incidence rate of hemorrhage on week 1 after surgery
研究概览
简要总结
This study evaluates the viability and safety of no drainage tube placement during transoral endoscopic thyroidectomy vestibular approach in treatment of patients with papillary thyroid carcinoma.
详细描述
Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is widely used due to its excellent cosmetic effect without scars on the body surface. In prevention of postoperative hemorrhage, a postoperative drainage tube is routinely placed in the surgical area. However, current opinion suggest that under the circumstance of strict and effective intraoperative hemostasis, routine application of drainage tube is unnecessary in conventional open thyroidectomy(COT). The research about drainage placement decision during endoscopic thyroidectomy is scarce currently. This study evaluates the viability and safety of no drainage tube placement during TOETVA on papillary thyroid carcinoma.
Patients allocated to the intervention group will implace no drainage tube during TOETVA and those allocated in control group will implace one drainage tube routinely.
The incidence of postoperative complications will be evaluated. The time of postoperative hospital-stay and operation time will be evaluated as well. At the same time, blood test results like WBC and CRP will be evaluated 1 day after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing thyroid surgery for the first time
- •The surgical method is TOETVA
- •There is no lateral cervical lymph node metastasis assessed before surgery
- •Fine-needle aspiration revealed palpilary thyroid carcinoma
- •It meets the surgical indications and has no obvious surgical contraindications
排除标准
- •previous history of thyroid surgery;
- •conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach;
- •patients undergoing cervical lateral lymph node dissection;
- •past or current history of hyperthyroidism;
- •history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.
研究组 & 干预措施
Routine application of drainage tube
After TOETVA, patients will receive one drainage tube through anterior cervical area.
Omission of drainage tube
After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.
干预措施: no drainage tube applied (Procedure)
结局指标
主要结局
The incidence rate of hemorrhage on week 1 after surgery
时间窗: 1 week
To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)
The incidence rate of infections on week 2 after surgery
时间窗: 2 week
To evaluate the incidence rate of infections of surgical sites
The incidence rate of postoperative hematoma or seroma on week 2 after surgery
时间窗: 2 week
To evaluate the incidence rate of postoperative hematoma or seroma
次要结局
- Body temperature on day 1 after surgery(1 day)
- Length of post-operative hospital stay(1 week)
- Pain score on day 1 after surgery(1 day)
- WBC on day 1 after surgery(1 day)
- CRP on day 1 after surgery(1 week)