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

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.

3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.

Inclusion Criteria:

• 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 Criteria:

• History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
• Clinical suspicion of metastases (stage cN1/cM1)
• Horseshoe kidney
• Previous malignancy with ongoing or planned nephrotoxic chemotherapy
• Multifocal kidney tumour
• Von Hippel-Lindau syndrome and other hereditary kidney cancer syndromes
• Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
• Tumor thrombus in Vena renalis or Vena cava inferior
• 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 decline data collection and storage for the main study