Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Thymoma, Myasthenia Gravis Associated With Thymoma, Thymectomy

Intervention / Treatment
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* Procedure: Sigle port RATS
* Procedure: Two ports RATS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy. Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent. Exclusion Criteria: Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication. Thymic carcinoma. Thoracic deformity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymectomy performed with sigle port RATS<br>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. | Procedure: Sigle port RATS<br>* 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.<br>|
| Active Comparator: Thymectomy performed with two ports RATS<br>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. | Procedure: Two ports RATS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operation pain | Measured with Visual Analogue Score (VAS-score)，the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome. | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical bleeding | Surgical bleeding measured with milliliter | During operation | 
| Operation duration | Operation duration measured with minute | During operation | 
| Quality of life after surgery | 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. | 6 months | 
| Curative effect | Disease free survival 5 years after surgery | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thymoma, Myasthenia Gravis, Thymectomy, Robotic Assisted Thoracic Surgery