Renal Tumors
Conditions
Keywords
renal tumor, robot assisted partial nephrectomy, 3D model, surgical navigation
Brief summary
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. * Investigational Medical Device: RUS NE (Endoscopic Imaging Treatment Planning Software) * Clinical Trial duration: 24 months from IRB approval -Target number of subjects: Total of 204 participants
Detailed description
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.
Interventions
DEVICERUS NE
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.
Sponsors
Asan Medical Center
Seoul National University Hospital
Samsung Medical Center
Chonnam National University Hospital
Kyungpook National University Hospital
Severance Hospital
Hutom Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy * The diameter of renal tumor is 7cm or below * Individuals aged between 19 and 80 * Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form
Exclusion criteria
* Individuals with solitary kidney or horseshoe kidney * Individuals undergo bilateral nephrectomy * Individuals undergo operation other than partial nephrecotmy * Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes * Individuals with severe chronic kidney disease (eGFR \< 45, calculated with EPI-CKI equation) * Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI * Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study * Individuals who were participated in other clinical study within 4 weeks of screening * Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | The operative day (operative day ± 5 days) | The duration of time between starting a surgical incision to the last sutures of the operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor and vessel identification time | The operative day (operative day ± 5 days) | The duration of time between starting manipulation of the surgeon console to the finishing dissection of the hilum and perinephric fat |
| Resection volume | From the postoperative 1week to the postoperative 5 weeks | Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π/6XYZ) |
| Postoperative complications | From the postoperative 8 weeks to the postoperative 16 weeks | 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. |
Countries
South Korea
Contacts
Primary ContactCheryn Song, M.D.,Ph.D.
Backup ContactSuh Min Kim, M.D.,Ph.D.
Outcome results
None listed