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NCT Number: NCT06290427

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

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.

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Key information

Conditions

Renal Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DaVinci RAPN

Device

Robot-assisted Partial Nephrectomy with DaVinci® Surgical System

Hugo RAS RAPN

Device

Robot-assisted Partial Nephrectomy with Hugo™ RAS System

Primary outcomes

  1. Number of participants with postoperative complications

    Time frame: 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

  2. Number of participants with moderate to major postoperative complications

    Time frame: 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

  3. Number of participants with major postoperative complications

    Time frame: 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 outcomes

  1. Overall duration of the surgery

    Time frame: Intraoperative

    Minutes

  2. Number of intraoperative complications

    Time frame: Intraoperative

    Proportion of events

  3. Type of intraoperative complications

    Time frame: Intraoperative

    Note of the event detail

  4. Number of intraoperative technical malfunctions

    Time frame: Intraoperative

    Proportion of events

  5. Type of intraoperative technical malfunctions

    Time frame: Intraoperative

    Note of the event detail

  6. Estimated Blood Loss

    Time frame: Intraoperative

    Volume

  7. Postoperative hospitalization

    Time frame: From the day after surgery up to 10 days postoperative

    Days of recovery until the date of discharge

  8. Postoperative pain

    Time frame: 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"

  9. Positive Surgical Margins

    Time frame: Up to 2 weeks postoperative (at the end of histological analysis)

    Rate after histological examination

  10. Serum Creatinine dosage for renal function assessment

    Time frame: 1 month, 3 and 6 months follow-up

    Creatinine test

  11. Estimated Glomerular Filtration Rate for renal function assessment

    Time frame: 1 month, 3 and 6 months follow-up

    eGFR calculation estimated by EPI-CKD formula

  12. 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)

    Configuration of the surgical table, Draping, Undraping, Docking, Undocking

  13. Procedure-related costs

    Time frame: From surgical procedure to the end of follow-up period (6 months)

    Estimate

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro AA Antonelli, MD

CONTACT

[email protected]

+39 0458127701

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney

Acronym: COMPAR-K

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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