Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform
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
- The protocol lists: Radical prostatectomy, Partial nephrectomy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Adenocarcinoma), Renal Cancer. 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
HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform
Overview
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).
Detailed description
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.
Interventions
- Procedure Radical prostatectomy
Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform - Procedure Partial nephrectomy
partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform
Primary outcome measures
- Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications [Time frame: 90 days]
Secondary outcome measures (12)
- 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 [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]
- 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 [Time frame: 5 years]
- functional outcomes of PR or PN surgery: - Number of pads used [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
Patients with Prostate Cancer (Group A)
- Age ≥ 18 years.
- Life expectancy greater than 10 years.
- Diagnosis of prostate cancer following prostate needle biopsy.
- Clinical stage cT1-T3b, N0-1 disease.
- Positive anesthetic fitness assessment for robot-assisted radical prostatectomy.
- Provision of informed consent for the study.
Patients with Kidney Cancer (Group B)
- Age ≥ 18 years.
- Radiological diagnosis of organ-confined kidney cancer at clinical stage T1a or T1b.
- Underwent CT and/or MRI of the abdomen with contrast medium.
- Positive anesthetic fitness assessment for robot-assisted partial nephrectomy.
- Provision of informed consent for the study.
Exclusion criteria
Patients with Prostate Cancer (Group A)
- Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
- Metastatic prostate cancer (M1).
- Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.
Patients with Kidney Cancer (Group B)
- Indication for radical nephrectomy.
- Metastatic kidney cancer (M1).
- Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06844513 · URO ROBOT 2023