The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Post-operative recurrent laryngeal nerve palsy
研究概览
简要总结
This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.
详细描述
Type of Study This is a single center, prospective case series
Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calculation.
Study Population Patients (> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma.
Study Design This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.
Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma.
- •Total thyroid size is 7-8 cm (no more than 10 cm)
- •Their age is ≥18 years and ≤80 years
- •Able to give written consent
排除标准
- •- History of neck surgery or neck radiotherapy
- •Recurrent thyroid disease
- •Lymph node metastases
- •Presence of intraoral infections
- •Presence of extrathyroidal or substernal extensions
- •Morbid obesity
- •Contra-indication to general anesthesia with nasotracheal intubation
- •Previous mediastinal surgery
- •Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle)
- •Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure
结局指标
主要结局
Post-operative recurrent laryngeal nerve palsy
时间窗: 12 months
Number of participants with post-operative recurrent laryngeal nerve palsy
Rate of gas-induced embolism
时间窗: 12 months
Number of participants with gas-induced embolism
Rate of subcutaneous emphysema
时间窗: 12 months
Number of participants with subcutaneous emphysema
Surgical time
时间窗: until surgical discharge, average of 24 hours
Surgical time in hours
Length of stay
时间窗: until surgical discharge, average of 24 hours
Length of stay in days
Postoperative hypocalcemia
时间窗: 12 months
Number of participants with postoperative hypocalcemia
Neck incision
时间窗: 1 month
Number of conversions to open
Rate of oral infections
时间窗: 12 months
Number of participants with oral infections
Rate of hematoma
时间窗: 1 month
Number of participants with hematomas
Rate of seroma
时间窗: 1 month
Number of participants with seromas
Rate of neck infection
时间窗: 12 months
Number of participants with neck infections
次要结局
- Quality of Life Score(12 months)