Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)
- Conditions
- Renal Carcinoma
- Interventions
- Device: Hugo RAS RAPNDevice: DaVinci RAPNDevice: Versius® RAPN
- Registration Number
- NCT06290427
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hugo RAS system Hugo RAS RAPN Robot-assisted partial nephrectomy is performed using the Hugo RAS platform DaVinci system DaVinci RAPN Robot-assisted partial nephrectomy is performed using the DaVinci platform Versius system Versius® RAPN Robot-assisted partial nephrectomy is performed using the Hugo RAS platform
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of intraoperative technical malfunctions Intraoperative Proportion of events
Postoperative hospitalization From the day after surgery up to 10 days postoperative Days of recovery until the date of discharge
Estimated Blood Loss Intraoperative Volume
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
Type of intraoperative technical malfunctions Intraoperative Note of the event detail
Number of intraoperative complications Intraoperative Proportion of events
Type of intraoperative complications Intraoperative Note of the event detail
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"
Serum Creatinine dosage for renal function assessment 1 month, 3 and 6 months follow-up Creatinine test
Estimated Glomerular Filtration Rate for renal function assessment 1 month, 3 and 6 months follow-up eGFR calculation estimated by EPI-CKD formula
Procedure-related costs From surgical procedure to the end of follow-up period (6 months) Estimate
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
Trial Locations
- Locations (1)
Urology Unit, AOUI Verona
🇮🇹Verona, VR, Italy