Using 3D modeling to improve robotic kidney surgery outcomes

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

This study is testing if using 3D models instead of 2D models can help make robotic kidney surgery quicker and safer for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 370 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Leipzig (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Dresden, Saxonia and 7 other locations)
• Trial ID: NCT06056505 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether virtual interactive 3D modeling can reduce total console operation time during robotic-assisted partial nephrectomy compared to traditional 2D modeling. It is a multicenter, randomized, controlled trial where patients will be assigned to receive either 3D or 2D modeling prior to their surgery. The study will also assess perioperative complications and morbidity as secondary outcomes, with a follow-up visit scheduled six months post-surgery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with kidney tumors measuring 7 cm or less who are scheduled for robotic-assisted partial nephrectomy.

Not a fit: Patients with a history of kidney surgery, severe renal insufficiency, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to shorter surgery times and improved patient outcomes in kidney tumor surgeries.

How similar studies have performed: While the use of 3D modeling in surgical procedures is gaining interest, this specific approach in robotic-assisted nephrectomy is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Dresden, Saxonia and 7 other locations

• Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie — Dresden, Saxonia, Germany (Recruiting)
• Leipzig University, Department of Urology — Leipzig, Saxonia, Germany (Recruiting)
• Sana Klinikum Borna, Klinik für Urologie — Borna, Germany (Not_yet_recruiting)
• St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie — Gronau, Germany (Recruiting)
• Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie — Homburg, Germany (Recruiting)
• Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie — Magdeburg, Germany (Not_yet_recruiting)
• Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie — Mainz, Germany (Not_yet_recruiting)
• Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie — Mannheim, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Sigrun Holze, Dr.

Conditions Kidney Tumor; DaVinci Surgical System; robotic-assisted partial nephrectomy; Kidney tumours