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A prospective observational study aimed at evaluating the feasibility, safety, and effectiveness of the Da Vinci SP robotic system for urologic procedures at IRCCS Candiolo. The study collects perioperative, oncologic, and functional outcomes, with exploratory comparisons to the multiport Da Vinci Xi system.
Minimally invasive surgery has significantly evolved with the introduction of robotic systems. The Da Vinci Single Port (SP) system, FDA-approved in 2018, allows procedures to be performed through a single incision. This single-center, prospective observational study conducted at IRCCS Candiolo aims to assess the safety, feasibility, and perioperative, oncologic, and functional outcomes of urologic procedures performed with the Da Vinci SP system.
Patients will be followed for up to 60 months post-surgery, with exploratory analysis comparing outcomes to those from procedures performed with the Da Vinci Xi (multiport) system. Data will include perioperative variables, complications, renal function, urinary continence, sexual potency, and oncologic parameters. Statistical analyses will be performed using Stata.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Da Vinci SP Robotic Surgery Cohort | This cohort includes all patients undergoing urologic surgical procedures using the Da Vinci Single Port (SP) robotic platform at IRCCS Candiolo. The procedures may include radical prostatectomy, partial or radical nephrectomy, adenomectomy, and nephroureterectomy. All surgeries are performed through a single surgical incision using the SP system, without additional experimental interventions. The outcomes of this cohort will be observed prospectively, and perioperative, functional, and oncologic results will be analyzed. Exploratory comparisons may be made with outcomes from historical or contemporaneous multiport (Da Vinci Xi) procedures |
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| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complication rate | The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery). | Within 30 days post-surgery |
| Conversion rate of SP robotic surgery | Feasibility of performing urologic surgeries using the Da Vinci SP system will be evaluated in terms of conversion rate to multiport surgeries or open approach | Surgery through 30 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical margins | Oncologic outcomes will include: - the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination) | Up to 60 months |
| BCR | Oncologic outcomes will include: - biochemical recurrence rates (BCR- defined as presence of biochemical recurrence for prostate cancer as PSA > 0.2 ng/dl; or presence of new tumoral lesions or metastasis for kidney and urothelial cancer) |
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Inclusion Criteria:
Exclusion Criteria:
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Age Range: 18 years and older Sex: All Healthy Volunteers: Not accepted Sampling Method: Non-probability sample Study Location: IRCCS Candiolo, Italy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrico Checcucci, MD | Contact | 00390119933623 | enrico.checcucci@ircc.it | |
| Annamaria Nuzzo, PHD | Contact | 00390119933844 | annamaria.nuzzo@ircc.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo | Recruiting | Candiolo | Turin | 10060 | Italy |
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| Up to 60 months |
| CSM | Oncologic outcomes will include: - long-term survival for patients who underwent oncologic urologic surgery.in terms of cancer specific mortality (CSM) | Up to 60 months |
| OM | Oncologic outcomes will include: - overall mortality (OM) | Up to 60 months |
| Continence recovery | This outcome will track urinary continence post-surgery, assessing the impact of the robotic approach on patients' quality of life. Continence will be defined as "total continence" (o pads) o "social continence" (1 safety pad). | 3 to 60 months post-surgery |
| Potency | This outcome will track sexual potency post-surgery, assessing the impact of the robotic approach on patients' quality of life. Potency will be defined as erection sufficient for intercourse or masturbation. IPSS and IEEF-5 questionnaires will be administered during the follow-up. | 3 to 60 months post-surgery |
| Renal Function | This outcome will trackrenal function post-surgery, assessing the impact of the robotic approach on patients' quality of life. It will be evaluated in terms of eGFR drop | 3 to 60 months post-surgery |
| Exploratory Endpoints (Comparison to Da Vinci Xi System) | An exploratory analysis will compare the Da Vinci SP system to the Da Vinci Xi multiport system. | End-of-study analysis (60 months) |