Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
研究概览
简要总结
Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication
详细描述
Prospective study carried out with ICESP patients with thyroid disease with surgical indication, according to the aforementioned inclusion criteria, totaling 60 cases, which will be randomized into two groups:
- Conventional Thyroidectomy (30 patients)
- Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of hypertrophic scarring and/or motivation to avoid cervical scarring,
- •maximum diameter of the thyroid < 10 cm and of the dominant nodule < 6 cm,
- •estimated thyroid volume < 45 ml
- •benign lesion (multinodular goiter, cyst),
- •indeterminate nodule (Bethesda III or IV),
- •suspicious nodule for well-differentiated thyroid carcinoma (Bethesda V and VI) < 2 cm
排除标准
- •history of previous surgery or irradiation in the head and neck region and superior mediastinum
- •evidence of clinical hyperthyroidism
- •preoperative recurrent nerve palsy
- •lymph node metastasis
- •extra-thyroid extension
- •plunging goiter
- •oral abscess
结局指标
主要结局
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction
时间窗: 1 year
This outcome will be accessed by performing laryngoscopy before and after the surgery
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury
时间窗: 1 year
This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation
时间窗: 1 year
This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization
时间窗: 1 year
This outcome will be accessed by number of days spent in the hospital
To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain
时间窗: 1 year
This outcome will be accessed by visual pain scale from grade 1 (better) to 10 (worse)
To compare TOETVA technique with conventional thyroidectomy in terms of operative time
时间窗: 1 year
Operative time will be measured by minutes
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism
时间窗: 1 year
This outcome will be accessed by accessing de blood calcium and parathormone levels after the surgery
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation
时间窗: 1 year
This outcome will be accessed by qualitative analysis
次要结局
- Comparison on quality of life - questionnaire 1.(1 year)
- Comparison on quality of life - questionnaire 2.(1 year)
- Comparison on quality of life - questionnaire 3.(1 year)
研究者
Fábio de Aquino Capelli
Principal Investigator
Instituto do Cancer do Estado de São Paulo