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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
DaVinci RAPN
DeviceRobot-assisted Partial Nephrectomy with DaVinci® Surgical System
Hugo RAS RAPN
DeviceRobot-assisted Partial Nephrectomy with Hugo™ RAS System
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
Secondary outcomes
Overall duration of the surgery
Minutes
Number of intraoperative complications
Proportion of events
Type of intraoperative complications
Note of the event detail
Number of intraoperative technical malfunctions
Proportion of events
Sponsors and contacts
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