Status:
RECRUITING
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
Lead Sponsor:
University of Leipzig
Conditions:
Kidney Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-assi...
Detailed 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 randomisat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06056505
Start Date
October 24 2023
End Date
September 30 2026
Last Update
December 9 2024
Active Locations (8)
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1
Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie
Dresden, Saxony, Germany, 01307
2
Leipzig University, Department of Urology
Leipzig, Saxony, Germany, 4103
3
Sana Klinikum Borna, Klinik für Urologie
Borna, Germany, 04552
4
St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie
Gronau, Germany, 48599