Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer (Adenocarcinoma); Renal Cancer

• Registration Number: NCT06844513
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-03-31
• Primary Completion: 2028-01-01
• Study Completion: 2033-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications	90 days	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.

Secondary Outcome Measures

Name	Time	Method
functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function	5 years	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).
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: Instrument conflicts or malfunctions	during surgery	Instrument conflicts and malfunctions will be calculated (in number and %)
Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins	90 days after surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times	during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.	up to 4 days
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss	during surgery
functional outcomes of PR or PN surgery: - Number of pads used	5 years
Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.	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
Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time	5 years

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy