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

Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney

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 Overview

• Status: Recruiting
• Conditions: Renal Carcinoma
• Intervention / Treatment: Device: DaVinci RAPN; Device: Hugo RAS RAPN

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro AA Antonelli, MD; Phone Number: +39 0458127701; Email: alessandro.antonelli@aovr.veneto.it

Study Locations

• Italy
  • VR
    • Verona, VR, Italy, 37126
      • Recruiting
      • Urology Unit, AOUI Verona
      • Contact: Alessandro AA Antonelli, MD; Phone Number: +39 0458127701; Email: alessandro.antonelli@aovr.veneto.it
      • Contact: Unità Ricerca Clinica; Phone Number: +39 0458122844; Email: unita.ricerca.clinica@aovr.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DaVinci system; Robot-assisted partial nephrectomy is performed using the DaVinci platform	Device: DaVinci RAPN; Robot-assisted Partial Nephrectomy with DaVinci® Surgical System
Experimental: Hugo RAS system; Robot-assisted partial nephrectomy is performed using the Hugo RAS platform	Device: Hugo RAS RAPN; Robot-assisted Partial Nephrectomy with Hugo™ RAS System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Over the 4 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood Loss	Volume	Intraoperative
Overall duration of the surgery	Minutes	Intraoperative
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"	1-4 days postoperative
Procedure-related costs	Estimate	From surgical procedure to the end of follow-up period (6 months)
Number of intraoperative complications	Proportion of events	Intraoperative
Type of intraoperative complications	Note of the event detail	Intraoperative
Number of intraoperative technical malfunctions	Proportion of events	Intraoperative
Type of intraoperative technical malfunctions	Note of the event detail	Intraoperative
Postoperative hospitalization	Days of recovery until the date of discharge	From the day after surgery up to 10 days postoperative
Positive Surgical Margins	Rate after histological examination	Up to 2 weeks postoperative (at the end of histological analysis)
Serum Creatinine dosage for renal function assessment	Creatinine test	1 month, 3 and 6 months follow-up
Estimated Glomerular Filtration Rate for renal function assessment	eGFR calculation estimated by EPI-CKD formula	1 month, 3 and 6 months follow-up
Time taken for platform related timings	Configuration of the surgical table, Draping, Undraping, Docking, Undocking	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)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Principal Investigator: Alessandro AA Antonelli, MD, Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): December 12, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative complications; Robotic-assisted surgery; Partial Nephrectomy; Operative outcomes; Multiple surgical platforms
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
• Other Study ID Numbers: COMPAR-K

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes