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

Recruiting

• Conditions: Urologic Surgical Procedure

• Registration Number: NCT07032194
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Brief Summary

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.

Study Timeline

• Study Start: 2025-02-19
• Study First Submitted: 2025-05-13
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative complication rate	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).
Conversion rate of SP robotic surgery	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 Outcome Measures

Name	Time	Method
Surgical margins	Up to 60 months	Oncologic outcomes will include: - the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination)
BCR	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)
CSM	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)
OM	Up to 60 months	Oncologic outcomes will include: - overall mortality (OM)
Continence recovery	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).
Potency	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.
Renal Function	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
Exploratory Endpoints (Comparison to Da Vinci Xi System)	End-of-study analysis (60 months)	An exploratory analysis will compare the Da Vinci SP system to the Da Vinci Xi multiport system.

Trial Locations

Locations (1)

Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo; 🇮🇹 Candiolo, Turin, Italy