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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Chonnam National University Hospital |
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This sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of RUS NE Surgical Navigation System in patients undergoing robotic-assisted partial nephrectomy. The trial will compare the experimental group (n=102) using RUS NE with a control group (n=102), aiming to show an 10% reduction in operation time. The study will involve 6 medical centers in South Korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies.
After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE. |
|
| Control arm | No Intervention | Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RUS NE | Device | The RUS NE is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the intra-abdominal surgical environments, allowing for the visualization of tumor, vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS NE utilizes preoperative CT images of the patients to segment tumor, organs, and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention on the patient, the surgeon uses RUS NE as a surgical navigation tool to simulate the surgery before performing the actual procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | The duration of time between starting a surgical incision to the last sutures of the operation. | The operative day (operative day ± 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor and vessel identification time | The duration of time between starting manipulation of the surgeon console to the finishing dissection of the hilum and perinephric fat | The operative day (operative day ± 5 days) |
| Resection volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheryn Song, M.D.,Ph.D. | Contact | 82-2-3010-5992 | cherynsong@amc.seoul.kr | |
| Suh Min Kim, M.D.,Ph.D. | Contact | 82-2-6956-0426 | smkim@hutom.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Cheryn Song, M.D.,Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Recruiting | Kwangju | Jeollanam-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39945060 | Result | Lee S, Lee HY, Song C. Assessment of Feasibility and Outcomes of RUS Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Small Renal Masses. Int J Urol. 2025 May;32(5):576-583. doi: 10.1111/iju.70014. Epub 2025 Feb 13. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| Kyungpook National University Hospital | OTHER |
| Severance Hospital | OTHER |
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Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π/6XYZ)
| From the postoperative 1week to the postoperative 5 weeks |
| Postoperative complications | Incidence of postoperative complications occurred within 4 weeks after the operation. The complications include urine leak, acute kidney injury, renal hemorrhage, fluid collection, abscess, and pulmonary or cardiac complications. | From the postoperative 8 weeks to the postoperative 16 weeks |
| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |