The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN).
The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN). The study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. Once enrolled, patients will be randomized to undergo treatment using either the Da Vinci Xi platform (Intuitive Surgical) or the HUGO™ RAS platform (Medtronic) according to block randomization. Patients with prostate cancer (Group A), enrolled according to inclusion criteria, will be randomized to undergo RP treatment with the Da Vinci Xi platform (control group) or RP treatment with the HUGO™ RAS platform (study group). Patients with kidney cancer (Group B), enrolled according to inclusion criteria, will be randomized to undergo PN treatment with the Da Vinci Xi platform or PN treatment with the HUGO™ RAS platform. If the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the HUGO RAS platform prove to be equivalent to those obtained with the Da Vinci Xi platform, it should lead to a progressive increase in the use of the HUGO RAS platform, resulting in a reduction in the overall costs associated with robotic urological surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform
partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications
To demonstrate the equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications observed within 90 days post-surgery. This evaluation will be conducted separately for: Patients undergoing radical prostatectomy (RP). Patients undergoing partial nephrectomy (PN). perioperative complication rate of grade greater than or equal to Clavien-Dindo IIIa within 90 days after surgery will be calculated.
Time frame: 90 days
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions
Instrument conflicts and malfunctions will be calculated (in number and %)
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.
Time frame: up to 4 days
Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins
Time frame: 90 days after surgery
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Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.
Time frame: 5 years
Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time
Time frame: 5 years
Oncologic outcomes of PR or PN surgery : Overall survival
Time frame: 5 years
Oncologic outcomes of PR or PN surgery : Cancer-specific survival
Time frame: 5 years
functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function
The possible scores for the IIEF-5 range from 5 to 25, and erectile dysfunction is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Time frame: 5 years
functional outcomes of PR or PN surgery: - Number of pads used
Time frame: 5 years