Prospective Study on the Use of the Da Vinci SP System in Urological Surgery (SP-URO)

Fondazione del Piemonte per l'Oncologia

Status: Enrolling

Conditions: Urologic Surgical Procedure

Study type: Observational

Funder types: Other

Identifiers

NCT07032194

001-FPO25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Da Vinci SP Robotic Surgery Cohort

Description:

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