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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
To evaluate safety, surgical outcomes, patient characteristics, and patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operation of focus procedure with da Vinci SP Surgery System | Experimental | Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients with Upper Tract Urothelial Cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Da Vinci SP Surgical System | Device | Da Vinci SP Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of conversion rate | The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy. | During Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Parameters: Operative Time | First skin incision to closure of wound by minutes. | immediately after the surgery |
| Perioperative Parameters: Console Time | Surgeon on Console Time by minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SHIH-CHIEH CHUEH, DIRECTOR | Contact | 02 23123456 | 262134 | jeffchueh@gmail.com |
| Taiwan National Taiwan University Hospital, DIRECTOR | Contact | 02 23123456 | 262134 | jeffchueh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shih-Chieh Chueh | National Taiwan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2024 | Dec 18, 2024 | Prot_000.pdf |
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| immediately after the surgery |
| Perioperative Parameters: Transfusion | Blood transfusion amount by bags | immediately after the surgery |
| Perioperative Parameters: Estimated Blood Loss | Estimated blood loss by mL | immediately after the surgery |
| Postoperative Parameters: Length of Stay | Total length of stay = discharge date - admission date | 30 days post operation |
| Complication | Intraoperative and/or postoperative complication rate in 30 days by Clavien-Dindo Classification | 30 days post operation |
| Postoperative Parameters: Readmission | Readmission rate by % | 30 days post operation |
| Postoperative Parameters: Reoperation | Reoperation rate by % | 30 days post operation |
| Perioperative Mortality | Mortality by % | 30 days post operation |
| Pain Score | measured by Visual Analogue Scale (VAS) for pain assessment at baseline, post operation, and discharge day. VAS ranged from 0 to 10, representing no pain to extreme pain. | 30 days post operation |