Renal Carcinoma
Conditions
Keywords
Robotic-assisted surgery, Partial Nephrectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes
Brief summary
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.
Interventions
DEVICEDaVinci RAPN
Robot-assisted Partial Nephrectomy with DaVinci® Surgical System
DEVICEHugo RAS RAPN
Robot-assisted Partial Nephrectomy with Hugo™ RAS System
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative complications | Over the 4 days post surgery | 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 | Over the 4 days post surgery | 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 | Over the 4 days post surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Estimated Glomerular Filtration Rate for renal function assessment | 1 month, 3 and 6 months follow-up | eGFR calculation estimated by EPI-CKD formula |
| Postoperative pain | 1-4 days postoperative | 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 |
| Positive Surgical Margins | Up to 2 weeks postoperative (at the end of histological analysis) | Rate after histological examination |
| Overall duration of the surgery | Intraoperative | Minutes |
| Number of intraoperative complications | Intraoperative | Proportion of events |
| Estimated Blood Loss | Intraoperative | Volume |
| Number of intraoperative technical malfunctions | Intraoperative | Proportion of events |
| Type of intraoperative technical malfunctions | Intraoperative | Note of the event detail |
| Time taken for platform related timings | 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) | Configuration of the surgical table, Draping, Undraping, Docking, Undocking |
| Procedure-related costs | From surgical procedure to the end of follow-up period (6 months) | Estimate |
| Type of intraoperative complications | Intraoperative | Note of the event detail |
| Serum Creatinine dosage for renal function assessment | 1 month, 3 and 6 months follow-up | Creatinine test |
| Postoperative hospitalization | From the day after surgery up to 10 days postoperative | Days of recovery until the date of discharge |
Countries
Italy
Contacts
Primary ContactAlessandro AA Antonelli, MD
Outcome results
None listed