Prospective Study on the Use of the Da Vinci SP System in Urological Surgery

Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)

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.

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