Myasthenia Gravis Associated With Thymoma, Thymectomy, Thymoma
Conditions
Keywords
Thymoma, Myasthenia Gravis, Thymectomy, Robotic Assisted Thoracic Surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESigle port RATS
The incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously.
PROCEDURETwo ports RATS
The incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy. 2. Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.
Exclusion criteria
1. Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication. 2. Thymic carcinoma. 3. Thoracic deformity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operation pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical bleeding | During operation | Surgical bleeding measured with milliliter |
| Operation duration | During operation | Operation duration measured with minute |
| Quality of life after surgery | 6 months | Measured with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30 questionnaire), the higher scores mean a better outcome. |
| Curative effect | 5 years | Disease free survival 5 years after surgery |
Countries
China
Contacts
Primary Contactlei jiang, doctor
Outcome results
None listed