Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate (COMPAR-P)

Integrated University Hospital Trust of Verona

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: DaVinci RARP; Device: Versius RARP; Device: Hugo RARP

Study type: Interventional

Funder types: Other

Identifiers

NCT05766163

COMPAR-P

Details and patient eligibility

About

The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms:

• DaVinci;
• Hugo;
• Versius.

The questions it aims to answer are:

• Does the estimation of the post-operative complications suggest something?
• Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?

Participants will be invited to fill out questionnaires and join one of these three groups:

1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 and < 90 years;
• Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
• Informed consent provided.

Exclusion criteria

• Age < 18 and > 90 years;
• Contraindication to radical prostatectomy procedure;
• Non-organ confined prostate cancer;
• Refusal to participate.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

DaVinci system

Active Comparator group

Description:

Robot-assisted radical prostatectomy is carried out through daVinci platform.

Treatment:

Device: DaVinci RARP

Hugo system

Experimental group

Description:

Robot-assisted radical prostatectomy is carried out through Hugo platform.

Treatment:

Device: Hugo RARP

Versius system

Experimental group

Description:

Robot-assisted radical prostatectomy is carried out through Versius platform.

Treatment:

Device: Versius RARP