A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Voice quality of life
研究概览
简要总结
To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.
详细描述
This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Benign thyroid nodule less than 4cm
- •Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
排除标准
- •Patients under 18 years old
- •Contraindication to general anaesthesia
- •Vulnerable population (e.g. Cognitive impairment, pregnant)
- •Previous anterior neck surgery
- •Previous radiotherapy at the head and neck region
- •Malignant thyroid nodule > 2cm
- •Presence of another malignancy, lateral neck, or distant metastasis
- •Retrosternal goitre
- •Cervical spine disease precluding extension of the neck
- •Obesity with BMI > 35kg/m2
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- •Untreated active infection
- •Non-correctable coagulopathy
- •Emergency surgery
结局指标
主要结局
Voice quality of life
时间窗: Post-operative 6 months
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Swallowing quality of life
时间窗: Post-operative 6 months
MD Anderson dysphagia inventory (MDADI)
Complication rate and types
时间窗: Post-operative 6 months
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Patient's satisfactory score
时间窗: Post-operative 6 months
Visual analogue scale 0-10
Post-operative pain
时间窗: Post-operative 6 months
Visual analogue scale 0-10
次要结局
- Rate of conversion to open surgery(Intra-operatively)
- Operative time(Intra-operatively)
- Inpatient stay(An average of 0-2 days after the operation)
- Blood loss(Intra-operatively)
研究者
YEUNG WING CHI ZENON
Consultant, Department of Otorhinolaryngology, Head and Neck Surgery
Tseung Kwan O Hospital, Hong Kong