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NCT Number: NCT07032194

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

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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Key information

Conditions

Urologic Surgical Procedure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Perioperative complication rate

    Time frame: Within 30 days post-surgery

    The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).

  2. Conversion rate of SP robotic surgery

    Time frame: Surgery through 30 postoperative days

    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

  1. Surgical margins

    Time frame: Up to 60 months

    Oncologic outcomes will include:

    • the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination)

  2. BCR

    Time frame: Up to 60 months

    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)

  3. CSM

    Time frame: Up to 60 months

    Oncologic outcomes will include:

    • long-term survival for patients who underwent oncologic urologic surgery.in terms of cancer specific mortality (CSM)

  4. OM

    Time frame: Up to 60 months

    Oncologic outcomes will include:

    • overall mortality (OM)

  5. Continence recovery

    Time frame: 3 to 60 months post-surgery

    This outcome will track urinary continence post-surgery, assessing the impact of the robotic approach on patients' quality of life.

    Continence will be defined as "total continence" (o pads) o "social continence" (1 safety pad).

  6. Potency

    Time frame: 3 to 60 months post-surgery

    This outcome will track sexual potency post-surgery, assessing the impact of the robotic approach on patients' quality of life.

    Potency will be defined as erection sufficient for intercourse or masturbation. IPSS and IEEF-5 questionnaires will be administered during the follow-up.

  7. Renal Function

    Time frame: 3 to 60 months post-surgery

    This outcome will trackrenal function post-surgery, assessing the impact of the robotic approach on patients' quality of life.

    It will be evaluated in terms of eGFR drop

  8. Exploratory Endpoints (Comparison to Da Vinci Xi System)

    Time frame: End-of-study analysis (60 months)

    An exploratory analysis will compare the Da Vinci SP system to the Da Vinci Xi multiport system.

Study contacts

Contact information is provided by the study sponsor or research team.

Annamaria Nuzzo, PHD

CONTACT

[email protected]

00390119933844

Enrico Checcucci, MD

CONTACT

[email protected]

00390119933623

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)

Acronym: SP-URO

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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