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| Name | Class |
|---|---|
| Qilu Hospital of Shandong University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. The trial was aimed to compare the perioperative outcomes between the two approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RATT | Experimental | robotic-assisted thoracoscopic thymectomy |
|
| VATT | Active Comparator | video-assisted thoracoscopic thymectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RATT | Procedure | Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative draingage volume | Postoperative draingage volume is the total draingage volume after surgery. | Up to 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| complete recestion rate | Up to 7 days. | |
| the counts of lymph node sampling | From the time at start of the surgery to the time at end of the surgery. Up to 7 days. | |
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Inclusion Criteria:
The patients whose tumor diameter was not larger than 8 cm; The patients with the estimated survival time should be over 12 months; ASA grade:1-2; The patients should have no functional disorders in main organs; The patients should be able to understand our research and sign the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianyong Ding, Ph.D. | Contact | 086+64041990 | ding.jianyong@zs-hospital.sh.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40441770 | Derived | Wang S, Zhu J, Sun Z, Jiang J, Wu B, Liang F, Zheng Y, Yang X, Jiang X, Ao YQ, Gao J, Tan L, Qi Y, Yue W, Ding J. Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I-II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial. BMJ Open. 2025 May 28;15(5):e095802. doi: 10.1136/bmjopen-2024-095802. |
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National policy.
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| ID | Term |
|---|---|
| C536905 | Thymic epithelial tumor |
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| VATT | Procedure | Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems. |
|
| operative time |
| From the time at start of the surgery to the time at end of the surgery. Up to 7 days. |
| bleeding volume | From the time at start of the surgery to the time at end of the surgery. Up to 7 days. |
| duration of drainage | from the day of the surgery to the day of removal of drainage tubes. Up to 7 days. |
| postoperative hospital stays | from the day of the surgery to the day of discharge. Up to 30 days |
| re-operation rate | from the day of the surgery to the day of discharge. Up to 7 days |
| C-reactive protein level at postoperaive day 1 | from the day of the surgery to the day of discharge. Up to 7 days |
| C-reactive protein level at postoperaive day 2 | from the day of the surgery to the day of discharge. Up to 7 days |
| serum interleukin-6 level at postoperaive day 1 | from the day of the surgery to the day of discharge. Up to 7 days |
| serum interleukin-6 level at postoperaive day 2 | from the day of the surgery to the day of discharge. Up to 7 days |
| serum procalcitonin level at postoperaive day 1 | from the day of the surgery to the day of discharge. Up to 7 days |
| serum procalcitonin level at postoperaive day 2 | from the day of the surgery to the day of discharge. Up to 7 days |
| pain visual analogue scale score at postoperative day 1, 2, 3 and 7 | from the day of the surgery to the postoperative day 7. Up to 7 days |
| quality of life score at postoperative day 30, 60 and 180 | from the day of the surgery to the postoperative day 180. Up to 180 days |
| complication rate | from the day of the surgery to the day of discharge. Up to 30 days |
| 3-year disease-free survival | from the day of the surgery to the postoperative 3 years. Up to 3 years |
| 3-year overall survival | from the day of the surgery to the postoperative 3 years. Up to 3 years |