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RecruitingNot ApplicableNCT06056505

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - a Multicentre, Randomised, Controlled Trial

Sponsor

University of Leipzig

Enrollment

370 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Kidney Tumor

Summary

The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System
  • CT scan with contrast medium available
  • Age ≥ 18 years
  • Written informed consent

Exclusion Criteria11

  • History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
  • Horseshoe kidney
  • Previous malignancy with ongoing or planned nephrotoxic chemotherapy
  • Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
  • Tumor thrombus in Vena renalis or Vena cava inferior
  • Existing renal insufficiency GFR \< 15 ml/min/1.73m2
  • Severe cognitive impairment
  • Pregnancy or lactation or women with desire for children
  • Patients under legal supervision or guardianship
  • Unable to give informed consent or suspected lack of compliance
  • Patients who refuse to data collection and storage for the main study

Interventions

PROCEDUREpartial kidney nephrectomy

surgery for partial nephrectomy

DEVICEDaVinci Robot

device to perform the surgery for partial nephrectomy (not the intervention of interest)

DEVICEInnersight 3D software

investigational product to generate the 3D model

Locations(8)

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie

Dresden, Saxony, Germany

Leipzig University, Department of Urology

Leipzig, Saxony, Germany

Sana Klinikum Borna, Klinik für Urologie

Borna, Germany

St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie

Gronau, Germany

Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie

Homburg, Germany

Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie

Magdeburg, Germany

Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie

Mainz, Germany

Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie

Mannheim, Germany

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