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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-19

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urologic Surgical Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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