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临床试验/NCT05262582
NCT05262582招募中不适用

Randomized Open Label Two Arms Cohort Study to Evaluate Curative Effect and Quality of Life of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Post operation pain

研究概览

简要总结

Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.

However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.

详细描述

The gold standard technique for thymectomy used to be transsternal approach. Advancements in modern technology bring many evolutions in minimally invasive surgery such as Video-assisted thoracic surgery (VATS) thymectomy gained popularity after 2000s. Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.

However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.

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

入选标准

  • Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
  • Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.

排除标准

  • Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
  • Thymic carcinoma.
  • Thoracic deformity.

结局指标

主要结局

Post operation pain

时间窗: 1 month after surgery

Measured with Visual Analogue Score (VAS-score),the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome.

次要结局

  • Curative effect(5 years)
  • Surgical bleeding(During operation)
  • Operation duration(During operation)
  • Quality of life after surgery(6 months)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lei Jiang

principal investigator

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

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