Clinical trial NCT06290427: Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)
Official title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Carcinoma
Keywords: Robotic-assisted surgery
Partial Nephrectomy
Multiple surgical platforms
Postoperative complications
Operative outcomes
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with postoperative complications
timeFrame: Over the 4 days post surgery
measure: Number of participants with moderate to major postoperative complications
timeFrame: Over the 4 days post surgery
measure: Number of participants with major postoperative complications
timeFrame: Over the 4 days post surgery
Secondary outcomes:
measure: Overall duration of the surgery
timeFrame: Intraoperative
measure: Number of intraoperative complications
timeFrame: Intraoperative
measure: Type of intraoperative complications
timeFrame: Intraoperative
measure: Number of intraoperative technical malfunctions
timeFrame: Intraoperative
measure: Type of intraoperative technical malfunctions
timeFrame: Intraoperative
measure: Estimated Blood Loss
timeFrame: Intraoperative
measure: Postoperative hospitalization
timeFrame: From the day after surgery up to 10 days postoperative
measure: Postoperative pain
timeFrame: 1-4 days postoperative
measure: Positive Surgical Margins
timeFrame: Up to 2 weeks postoperative (at the end of histological analysis)
measure: Serum Creatinine dosage for renal function assessment
timeFrame: 1 month, 3 and 6 months follow-up
measure: Estimated Glomerular Filtration Rate for renal function assessment
timeFrame: 1 month, 3 and 6 months follow-up
measure: Time taken for platform related timings
timeFrame: 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)
measure: Procedure-related costs
timeFrame: From surgical procedure to the end of follow-up period (6 months)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Urology Unit, AOUI Verona
state: VR
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Alessandro AA Antonelli, MD
role: PRINCIPAL_INVESTIGATOR
References: