Da Vinci SP single‑port robotic urologic surgery
Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
This project will try the Da Vinci SP single‑port robot in adults having urologic surgery to see if it is safe, feasible, and works well compared with the multiport Da Vinci Xi system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, Turin) |
| Trial ID | NCT07032194 on ClinicalTrials.gov |
What this trial studies
This is a single‑center, prospective observational project at IRCCS Candiolo collecting perioperative, oncologic, and functional outcomes after urologic procedures performed with the Da Vinci SP system. Patients are followed for up to 60 months after surgery with data on complications, renal function, urinary continence, sexual potency, and oncologic measures. The protocol includes exploratory comparisons to outcomes from procedures performed with the Da Vinci Xi multiport system. Statistical analyses will be performed using Stata to describe outcomes and compare groups where possible.
Who should consider this trial
Good fit: Ideal candidates are adults who meet clinical indications for robotic urologic surgery per guidelines, are fit for anesthesia with ECOG 0–1, have life expectancy ≥10 years, can provide informed consent, and can comply with follow‑up.
Not a fit: Patients who are unfit for anesthesia, not eligible for robotic surgery, have cognitive or psychiatric conditions preventing consent or follow‑up, or whose disease requires open surgery are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the Da Vinci SP approach could offer similar cancer and functional outcomes with fewer incisions, potentially less pain and faster recovery for some patients.
How similar studies have performed: Early case series and feasibility reports of single‑port robotic urologic procedures have shown promise, but large comparative data versus multiport systems remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Candiolo, Turin
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo — Candiolo, Turin, Italy (Recruiting)
Study contacts
- Study coordinator: Enrico Checcucci, MD
- Email: enrico.checcucci@ircc.it
- Phone: 00390119933623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.