NCT05263141已完成不适用
Single-center, Prospective, Non-Randomized Control Clinical Trial of Retro-Auricular Single-Site Endoscopic Versus Open Surgery in Patients With Early Stage Papillary Thyroid Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative cosmetic satisfaction scores
研究概览
简要总结
The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, no gender restrictions.
- •Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
- •Early stage PTC (stage T1N0M0).
- •Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis.
- •Patients undergoing thyroid lobectomy and central lymph node dissection.
- •Patients who have signed an approved Informed Consent.
排除标准
- •Patients who do not accept case data collection for various reasons.
- •The clinical data unfit this study (at the discretion of the investigator).
- •Patients who have undergone neck surgery or radiotherapy before this trail.
- •Patients who have uncontrolled hyperthyroidism.
结局指标
主要结局
postoperative cosmetic satisfaction scores
时间窗: 3 months from surgery
The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction).
次要结局
- Intra-operative, peri-operative, post-operative clinicopathologic characteristics(1 week from surgery)
- postoperative cosmetic satisfaction scores(1 month from surgery)
- postoperative Vancouver Scar Scale(1 month from surgery)
研究者
Ouyang Dian
Clinical Professor
Sun Yat-sen University
研究点 (1)
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