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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Robot-assisted Partial Nephrectomy with DaVinci® Surgical System
Robot-assisted Partial Nephrectomy with Hugo™ RAS System
Urology Unit, AOUI Verona
Verona, VR, Italy
RECRUITINGNumber 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
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
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
Overall duration of the surgery
Minutes
Time frame: Intraoperative
Number of intraoperative complications
Proportion of events
Time frame: Intraoperative
Type of intraoperative complications
Note of the event detail
Time frame: Intraoperative
Number of intraoperative technical malfunctions
Proportion of events
Time frame: Intraoperative
Type of intraoperative technical malfunctions
Note of the event detail
Time frame: Intraoperative
Estimated Blood Loss
Volume
Time frame: Intraoperative
Postoperative hospitalization
Days of recovery until the date of discharge
Time frame: From the day after surgery up to 10 days postoperative
Postoperative pain
Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 1-4 days postoperative
Positive Surgical Margins
Rate after histological examination
Time frame: Up to 2 weeks postoperative (at the end of histological analysis)
Serum Creatinine dosage for renal function assessment
Creatinine test
Time frame: 1 month, 3 and 6 months follow-up
Estimated Glomerular Filtration Rate for renal function assessment
eGFR calculation estimated by EPI-CKD formula
Time frame: 1 month, 3 and 6 months follow-up
Time taken for platform related timings
Configuration of the surgical table, Draping, Undraping, Docking, Undocking
Time frame: From the room setting, through the overall surgical procedure, until postoperative room restoration for each of expected 45 surgeries (through study completion: about 4 months)
Procedure-related costs
Estimate
Time frame: From surgical procedure to the end of follow-up period (6 months)
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