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The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.
Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RATS for Thymectomy | Experimental | The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted. |
|
| VATS for Thymectomy | Active Comparator | The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RATS for Thymectomy | Procedure | a minimally invasive surgical type for Thymoma: RATS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival (OS) | OS at 5 year after surgery | 5 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain | at 1 year after surgery |
| quality of life (QOL) at 1 year by EORTC QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juemin Yu | Contact | +8615927548511 | yujm96@163.com | |
| Deping Zhao, MD,PhD | Contact | +8613701816883 | zdp1992@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Deping Zhao, MD,PhD | Shanghai Pulmonary Hospital, School of Medicine, Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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| ID | Term |
|---|---|
| D013934 | Thymectomy |
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
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RATS versus VATS
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no masking
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| VATS for Thymectomy |
| Procedure |
a minimally invasive surgical type for Thymoma: VATS |
|
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0 |
| at 1 year after surgery |
| quality of life (QOL) at 1 year by EQ-5D | Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D). | at 1 year after surgery |
| R0 rate | R0 radical rate | postoperative in-hospital stay up to 30 days |
| operative time | the time of operation | Intraoperative |
| blood loss | blood loss in the operation | Intraoperative |
| conversion rate | the rate of conversion to open surgery in the operation | Intraoperative |
| length of hospital stay (LOS) | length of stay in hospitalization | postoperative in-hospital stay up to 30 days |
| Catheterization days | The interval days from the completion of catheter insertion to the removal of the thoracic tube | postoperative in-hospital stay up to 30 days |
| Volume of drainage | Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube | postoperative in-hospital stay up to 30 days |
| postoperative complications | mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula | postoperative in-hospital stay up to 30 days |
| 30-day mortality | 30-day mortality after surgery | postoperative in-hospital stay up to 30 days |
| 30-day readmission rate after surgery | Rate of readmission due to postoperative complications | postoperative in-hospital stay up to 30 days |
| 5-year disease-free survival (DFS) | DFS at 5 year after surgery | 5 year after surgery |
| Tumor recurrence rate | The rate of recurrence of thymoma in patients after surgery | 5 year after surgery |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Zhejiang | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003949 |
| Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |