Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,264
- 试验地点
- 1
- 主要终点
- Rate of complications
研究概览
简要总结
Recent trends in the management of patients with low-risk papillary thyroid carcinoma who have a nonsuspicious or cytologically benign contralateral nodule call into question the need for routine total thyroidectomy. Although the lobectomy for the unilateral thyroid cancer with contralateral benign nodules is sufficient treatment, some of the patients might suffer from the anxiety of the residual benign thyroid nodule and tend to choose total thyroidectomy, which might be overtreatment.
Thermal ablation has been proven to be effective in achieving nodule shrinkage and being also free from major complications. In our institution, intraoperative RFA was a proposed alternative strategy to treat the contralateral benign nodules after the thyroid lobectomy for the malignant lobe, which was found to have a better quality of life on anxiety, physiological health, social family, psychological and sensory mentions with a considerable complication rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology;
- •Patients with contralateral nodules ≤ 20mm and located in the thyroid gland;
- •Patients with clinical node-negative cervical compartment at palpation and neck ultrasound.
排除标准
- •Previous history of neck surgery
- •Previous history of neck radiation therapy
结局指标
主要结局
Rate of complications
时间窗: Up to 2 years
Transient or persistent hypoparathyroidism confirmed by serum calcium levels was less than the lower limit at examination center and had symptoms of hypocalcemia. Postoperative vocal cord paralysis was defined as fixed vocal cord mobility with laryngofiberoscopic examination.
Scores of hospital anxiety and depression scale (HADS)
时间窗: Up to 6 months
All patients were requested to answer the HADS questionnaire, the scores of which were recorded.
Scores of fear of progression questionnaire-short form(FPQS)
时间窗: Up to 6 months
All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.
Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire
时间窗: Up to 6 months
All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.
Rate of recurrence
时间窗: 5-year estimate reported after a median follow-up of 60 months
Lymph node recurrence or distant recurrence
次要结局
未报告次要终点
研究者
Gaosong Wu, Ph D, MD
Director
Wuhan University