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Recruiting NCT06290427

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

No phase Interventional Renal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DaVinci RAPN, Hugo RAS RAPN.
Who it may be relevant to
Registry conditions: Renal Carcinoma. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney

Overview

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

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

Primary outcome measures

  • Number of participants with postoperative complications [Time frame: Over the 4 days post surgery]
  • Number of participants with moderate to major postoperative complications [Time frame: Over the 4 days post surgery]
  • Number of participants with major postoperative complications [Time frame: Over the 4 days post surgery]
Secondary outcome measures (12)
  • Overall duration of the surgery [Time frame: Intraoperative]
  • Number of intraoperative complications [Time frame: Intraoperative]
  • Type of intraoperative complications [Time frame: Intraoperative]
  • Number of intraoperative technical malfunctions [Time frame: Intraoperative]
  • Type of intraoperative technical malfunctions [Time frame: Intraoperative]
  • Estimated Blood Loss [Time frame: Intraoperative]
  • Postoperative hospitalization [Time frame: From the day after surgery up to 10 days postoperative]
  • Postoperative pain [Time frame: 1-4 days postoperative]
  • Positive Surgical Margins [Time frame: Up to 2 weeks postoperative (at the end of histological analysis)]
  • Serum Creatinine dosage for renal function assessment [Time frame: 1 month, 3 and 6 months follow-up]
  • Estimated Glomerular Filtration Rate for renal function assessment [Time frame: 1 month, 3 and 6 months follow-up]
  • Time taken for platform related timings [Time frame: 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • Urology Unit, AOUI Verona — Verona

Identifiers

NCT: NCT06290427 · COMPAR-K

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗