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.
Study Type
OBSERVATIONAL
Enrollment
250
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo
Candiolo, Turin, Italy
RECRUITINGPerioperative complication rate
The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).
Time frame: 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
Time frame: Surgery through 30 postoperative days
Surgical margins
Oncologic outcomes will include: \- the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination)
Time frame: 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)
Time frame: 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)
Time frame: Up to 60 months
OM
Oncologic outcomes will include: \- overall mortality (OM)
Time frame: 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).
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Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: End-of-study analysis (60 months)