About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unsuitability for anesthesia
Cognitive or psychiatric disorders affecting consent or compliance
Trial population
Age Range: 18 years and older Sex: All Healthy Volunteers: Not accepted Sampling Method: Non-probability sample Study Location: IRCCS Candiolo, Italy
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Perioperative complication rate
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
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 outcomes
Surgical margins
Oncologic outcomes will include: \- the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination)
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)
CSM
Oncologic outcomes will include: \- long-term survival for patients who underwent oncologic urologic surgery.in terms of cancer specific mortality (CSM)
OM
Oncologic outcomes will include: \- overall mortality (OM)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.