Urologic Surgical Procedure
Conditions
Keywords
Da Vinci Single Port (SP) System, Urologic Surgery, multiport
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent and data privacy consent * Clinical indication for urologic robotic surgery per EAU guidelines or clinical trial eligibility * ECOG Performance Status 0-1 * Life expectancy ≥ 10 years * Availability of preoperative clinical data * Willingness to comply with follow-up visits and data collection * Eligibility for robotic surgery
Exclusion criteria
* Unsuitability for anesthesia * Cognitive or psychiatric disorders affecting consent or compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complication rate | Within 30 days post-surgery | The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery). |
| Conversion rate of SP robotic surgery | Surgery through 30 postoperative days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSM | Up to 60 months | Oncologic outcomes will include: \- long-term survival for patients who underwent oncologic urologic surgery.in terms of cancer specific mortality (CSM) |
| OM | Up to 60 months | Oncologic outcomes will include: \- overall mortality (OM) |
| Continence recovery | 3 to 60 months post-surgery | 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). |
| Surgical margins | Up to 60 months | Oncologic outcomes will include: \- the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination) |
| Renal Function | 3 to 60 months post-surgery | 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 |
| Exploratory Endpoints (Comparison to Da Vinci Xi System) | End-of-study analysis (60 months) | An exploratory analysis will compare the Da Vinci SP system to the Da Vinci Xi multiport system. |
| Potency | 3 to 60 months post-surgery | 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. |
| BCR | Up to 60 months | 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) |
Countries
Italy
Contacts
Primary ContactEnrico Checcucci, MD
Backup ContactAnnamaria Nuzzo, PHD
Outcome results
None listed