Overview
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.
Description
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.
Eligibility
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)
- 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