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

Renal Carcinoma Clinical Trial

— COMPAR-K  

Official title:

Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290427
• Other study ID #: COMPAR-K
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Alessandro AA Antonelli, MD
• Phone: +39 0458127701
• Email: alessandro.antonelli[@]aovr.veneto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 three currently available platforms:

• DaVinci®;

• Hugo®;

• Versius®.

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 three experimental group:

1. surgery with the DaVinci platform;

2. surgery with the Hugo platform;

3. surgery with the Versius platform.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Carcinoma

Intervention

Device:
• DaVinci RAPN
Robot-assisted Partial Nephrectomy with DaVinci® Surgical System
• Hugo RAS RAPN
Robot-assisted Partial Nephrectomy with Hugo™ RAS System
• Versius® RAPN
Robot-assisted Partial Nephrectomy with Versius® System

Locations

Country	Name	City	State
Italy	Urology Unit, AOUI Verona	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

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