Comparison of Quality of Life Between Patients with Early Differentiated Thyroid Cancer Undergoing Minimally Invasive and Open Surgery: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- change of quality of life (SF-36)
研究概览
简要总结
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment. Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing different surgery. The quality of life, voice, scar would be assessed by authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery is better than traditional open surgery in order to provide reliable evidence for clinical practice.
详细描述
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a good prognosis. For early differentiated thyroid cancer, surgery is the main treatment. Traditional open surgery would leave a scar on the neck, which is especially troublesome for female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing surgery according to a prospective cohort design. The evaluation questionnaires including quality of life, voice and scar would be completed to demonstrate that minimally invasive surgery is better than traditional open surgery not only in the way of effectiveness, but also in the quality of life. We hope to provide reliable evidence for clinical practice by this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 years and < 70 years;
- •Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary thyroid carcinoma, follicular carcinoma);
- •stage T1~T3a, N0~N1a, M0;
- •Ability to read and write Chinese;
- •Willingness to follow up.
排除标准
- •Age < 18 years old or ≥70 years old;
- •Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid carcinoma;
- •Aggressive histology: tall cell, columnar cell, hobnail variant, etc.
- •Mixed with medullary carcinoma or anaplastic thyroid carcinoma;
- •High risk of recurrence (according to ATA guideline);
- •Lateral cervical lymph node metastasis or distant metastasis;
- •Suffer from other malignant tumors;
- •History of thyroid surgery or cervical lymph node dissection;
- •Cognition or behavior impairment.
结局指标
主要结局
change of quality of life (SF-36)
时间窗: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
change of the scores of the SF-36（36-item Short-Form）questionaire
change of quality of life (Thyca-Qol)
时间窗: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
change of the scores of the Thyca-Qol（Thyroid Cancer-specific Quality of Life） questionaire
次要结局
- operation duration(Intraoperative)
- satisfaction of the surgery(1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- voice handicap index(baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- complications(baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- postoperative drainage(up to 1 week after surgery)
- level of calcium(baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- scores of the surgical scar(1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- level of thyroglobulin(baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- blood loss(up to 1 week after surgery)
研究者
Xiaoming Huang
Professor; Director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University