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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Da Vinci SP Robotic Surgery Cohort

Trial outcomes

Primary outcomes

1

Perioperative 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
2

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

Secondary outcomes

1

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
2

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
3

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
4

OM

Oncologic outcomes will include: \- overall mortality (OM)

Time frame
Up to 60 months

Other outcomes

Sponsors and contacts

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