Prospective Study on the Use of the Da Vinci SP System in Urological Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urologic Surgical Procedure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
Overview
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.
Detailed 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.
Primary outcome measures
- Perioperative complication rate [Time frame: Within 30 days post-surgery]
- Conversion rate of SP robotic surgery [Time frame: Surgery through 30 postoperative days]
Secondary outcome measures (8)
- Surgical margins [Time frame: Up to 60 months]
- BCR [Time frame: Up to 60 months]
- CSM [Time frame: Up to 60 months]
- OM [Time frame: Up to 60 months]
- Continence recovery [Time frame: 3 to 60 months post-surgery]
- Potency [Time frame: 3 to 60 months post-surgery]
- Renal Function [Time frame: 3 to 60 months post-surgery]
- Exploratory Endpoints (Comparison to Da Vinci Xi System) [Time frame: End-of-study analysis (60 months)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo — Candiolo
Identifiers
NCT: NCT07032194 · 001-FPO25