Effect of Reversed Tracking Method of Stimulating Cricothyroid Muscles on the Identification and Protection of EBSLN in Thyroid Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The identification rate of the external branch of the superior laryngeal nerve.
研究概览
简要总结
The feasibility and effectiveness of Reversed Tracking Method for the identification and protection of extralaryngeal nerve branches in thyroid surgery were analyzed. Evidence-based medical evidence was used to evaluate the importance of EBSLN recognition and protection in thyroid surgery.
详细描述
The incidence of thyroid cancer in the world is growing rapidly. The current incidence of thyroid cancer in China is about 4.2/100,000, ranking the fourth in the incidence of female malignant tumors. Surgical treatment is the first and most important treatment for thyroid cancer. According to the existing literature, the injury rate of EBSLN in thyroid surgery can be as high as 58%. The quality of sound changes caused by EBSLN injury affects the quality of life of patients after surgery, and even affects the work and career of patients. therefore, seeking better EBSLN protection The method has great social and economic benefits.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thyroid papillary cancer patients
- •thyroid adenoma patients
- •tumor diameter less than 4cm
- •patients who require only unilateral thyroid surgery as required by the guidelines
排除标准
- •The upper pole tumor invades the anterior dorsum and may accumulate the area of the superior laryngeal nerve;
- •Patients who have previously performed head and neck surgery;
- •Preoperative laryngoscopy and sound assessment abnormalities or previous vocal cord surgery history;
- •If there is a language or hearing impairment, the follow-up assessment cannot be completed;
- •The assessment failure of nerve function due to the technical deficiency of the IONM equipment
- •Elimination criteria:
- •Patients with recurrent laryngeal nerve palsy after surgery affect the evaluation of the laryngeal nerve.
- •The patient is asked to withdraw from the follow-up assessment midway.
研究组 & 干预措施
Standard method
Standard method recommended by the guide
Reversed Tracking Method
Reversed Tracking Method
干预措施: Reversed Tracking Method (Procedure)
结局指标
主要结局
The identification rate of the external branch of the superior laryngeal nerve.
时间窗: up to 6 months postoperatively
The identification rate of the external branch of the superior laryngeal nerve.
次要结局
- fundamental frequency (Fo)(up to 6 months postoperatively)
- videostrobolaryngoscopy(up to 6 months postoperatively)
- voice level (VL)(up to 6 months postoperatively)
- Friedman classification(up to 6 months postoperatively)
- analysis of maximum phonation time (MPT)(up to 6 months postoperatively)
- voice quality rating on GRBAS scale(up to 6 months postoperatively)
研究者
Bo Wang,MD
clinical professor
Fujian Medical University