A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The complication rate after TOETVA in 12 months
研究概览
简要总结
Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong.
The following are the procedure of the study:
- Recruit patients from the clinic.
- Patients will receive treatment within 3 months
- Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month.
- Patients will be monitoring by the same team after the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •have a cyst, nodule or a goiter which has been shown to be benign on fine needle aspiration cytology,
- •need to undergo a unilateral thyroid resection,
- •have a nodule size no larger than 4cm in largest diameter,
- •willing to undergo this new approach rather than the traditional open approach.
排除标准
- •unfit for surgery,
- •has had previous surgery or radiation at the neck,
- •unable to tolerate a general anesthesia,
- •wearing dental braces,
- •absence of vocal cord mobility at laryngoscopy.
结局指标
主要结局
The complication rate after TOETVA in 12 months
时间窗: 12 months
To record any complication of surgery in every post-operation visit after 12 months. The record will be used for the calculation of complication rate.
次要结局
- The pain score of patient after TOETVA(12 months)
- The satisfaction of patients after having TOETVA in 12 months(12 months)
- The open conversion rate of TOETVA(12 months)
- The wound infection rate after TOETVA(12 months)
- The hypoparathyroidism rate after TOETVA(12 months)
- The vocal cord palsy rate after TOETVA(12 months)
- The hematoma rate after TOETVA(12 months)
研究者
Dr. Lang Hung Hin, Brian
Clinical Associate Professor
The University of Hong Kong