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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prostate cancer | Active Comparator | Patients with prostate cancer (Group A), enrolled according to the inclusion criteria, are randomized to undergo radical prostatectomy (RP) using either the Da Vinci Xi platform (control group) or the HUGO™ RAS platform (study group). |
|
| kidney cancer | Active Comparator | patients with kidney cancer (Group B), enrolled according to the inclusion criteria, are randomized to undergo partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical prostatectomy | Procedure | Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators | during surgery | |
| Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times |
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Inclusion Criteria:
Patients with Prostate Cancer (Group A)
Patients with Kidney Cancer (Group B)
Exclusion Criteria:
Patients with Prostate Cancer (Group A)
Patients with Kidney Cancer (Group B)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eugenio Brunocilla, Prof, MD | Contact | +39 051 2142374 | eugenio.brunocilla@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Eugenio Brunocilla, Prof, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Partial nephrectomy | Procedure | partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform |
|
| 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 %) | during surgery |
| Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss | during surgery |
| Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay. | up to 4 days |
| Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins | 90 days after surgery |
| Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease. | 5 years |
| Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time | 5 years |
| Oncologic outcomes of PR or PN surgery : Overall survival | 5 years |
| Oncologic outcomes of PR or PN surgery : Cancer-specific survival | 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). | 5 years |
| functional outcomes of PR or PN surgery: - Number of pads used | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |