Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)

Integrated University Hospital Trust of Verona

Status: Enrolling

Conditions: Renal Carcinoma

Treatments: Device: DaVinci RAPN; Device: Hugo RAS RAPN

Study type: Interventional

Funder types: Other

Identifiers

NCT06290427

COMPAR-K

Details and patient eligibility

About

The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:

• DaVinci®;
• Hugo®.

The questions it aims to answer are:

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

Participants will be invited to join one of these two experimental group:

1. surgery with the DaVinci platform;
2. surgery with the Hugo platform.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient aged between 18 and 90 years old;
• patient with localized kidney tumor suitable for partial nephrectomy;
• patient able to understand and sign the informed consent;
• patient compliance with the follow-up program.

Exclusion criteria

• patient who do not fall within the inclusion age range;
• patient not suitable for partial nephrectomy;
• patient unable to understand and sign the informed consent;
• patient unable to follow the monitoring program;
• patient refusal to participate to the study.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

DaVinci system

Active Comparator group

Description:

Robot-assisted partial nephrectomy is performed using the DaVinci platform

Treatment:

Device: DaVinci RAPN

Hugo RAS system

Experimental group

Description:

Robot-assisted partial nephrectomy is performed using the Hugo RAS platform

Treatment:

Device: Hugo RAS RAPN