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The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:
The questions it aims to answer are:
Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?
Participants will be invited to join one of these two experimental group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaVinci system | Active Comparator | Robot-assisted partial nephrectomy is performed using the DaVinci platform |
|
| Hugo RAS system | Experimental | Robot-assisted partial nephrectomy is performed using the Hugo RAS platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaVinci RAPN | Device | Robot-assisted Partial Nephrectomy with DaVinci® Surgical System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with postoperative complications | Overall postoperative complications (% score >0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication | Over the 4 days post surgery |
| Number of participants with moderate to major postoperative complications | Moderate to major complications (% score >=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication | Over the 4 days post surgery |
| Number of participants with major postoperative complications | Major complications (% score >=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication | Over the 4 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall duration of the surgery | Minutes | Intraoperative |
| Number of intraoperative complications | Proportion of events | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro AA Antonelli, MD | Contact | +39 0458127701 | alessandro.antonelli@aovr.veneto.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro AA Antonelli, MD | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Unit, AOUI Verona | Recruiting | Verona | VR | 37126 | Italy |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Hugo RAS RAPN |
| Device |
Robot-assisted Partial Nephrectomy with Hugo™ RAS System |
|
| Type of intraoperative complications | Note of the event detail | Intraoperative |
| Number of intraoperative technical malfunctions | Proportion of events | Intraoperative |
| Type of intraoperative technical malfunctions | Note of the event detail | Intraoperative |
| Estimated Blood Loss | Volume | Intraoperative |
| Postoperative hospitalization | Days of recovery until the date of discharge | From the day after surgery up to 10 days postoperative |
| Postoperative pain | Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable" | 1-4 days postoperative |
| Positive Surgical Margins | Rate after histological examination | Up to 2 weeks postoperative (at the end of histological analysis) |
| Serum Creatinine dosage for renal function assessment | Creatinine test | 1 month, 3 and 6 months follow-up |
| Estimated Glomerular Filtration Rate for renal function assessment | eGFR calculation estimated by EPI-CKD formula | 1 month, 3 and 6 months follow-up |
| Time taken for platform related timings | Configuration of the surgical table, Draping, Undraping, Docking, Undocking | From the room setting, through the overall surgical procedure, until postoperative room restoration for each of expected 45 surgeries (through study completion: about 4 months) |
| Procedure-related costs | Estimate | From surgical procedure to the end of follow-up period (6 months) |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |