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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAzienda Ospedaliera Universitaria Integrata Verona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • DaVinci RAPN

    Device

    Robot-assisted Partial Nephrectomy with DaVinci® Surgical System

  • Hugo RAS RAPN

    Device

    Robot-assisted Partial Nephrectomy with Hugo™ RAS System

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: DaVinci systemActive comparator 1 intervention
Group B: Hugo RAS systemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with postoperative complications

Overall postoperative complications (% score \>0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

Time frame
Over the 4 days post surgery
2

Number of participants with moderate to major postoperative complications

Moderate to major complications (% score \>=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

Time frame
Over the 4 days post surgery
3

Number of participants with major postoperative complications

Major complications (% score \>=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

Time frame
Over the 4 days post surgery

Secondary outcomes

1

Overall duration of the surgery

Minutes

Time frame
Intraoperative
2

Number of intraoperative complications

Proportion of events

Time frame
Intraoperative
3

Type of intraoperative complications

Note of the event detail

Time frame
Intraoperative
4

Number of intraoperative technical malfunctions

Proportion of events

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

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