Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Operation time
研究概览
简要总结
Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thymoma with or without myasthenia gravis；
- •Generalized myasthenia gravis not sensitive to conservative medicine treatment;
- •Good cardiopulmonary function.
排除标准
- •Cardiopulmonary function can't bear surgery;
- •Generalized myasthenia gravis with MuSK(+).
研究组 & 干预措施
Subxiphoid group
Subxiphoid procedure for thymectomy.
干预措施: Subxiphoid surgery procedure (Procedure)
VATS group
Video-assisted thoracoscopic thymectomy through chest wall.
干预措施: VATS surgery procedure (Procedure)
结局指标
主要结局
Operation time
时间窗: one day
in minutes
Visual Analogue Scale of postoperative pain
时间窗: within 3 days
in score
Duration of drainage
时间窗: with 7 days
in days
The amount of blood loss
时间窗: one day
in milliliter
Duration of hospital stay
时间窗: with 7 days
in days
次要结局
- Complete remission rates(5 years)
- Recurrence rate(5 years)
- Overall survival(within 10 years)