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

University of Leipzig370 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

370

Conditions

Kidney Tumor

Interventions

partial kidney nephrectomyPROCEDURE

surgery for partial nephrectomy

DaVinci RobotDEVICE

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

Innersight 3D softwareDEVICE

investigational product to generate the 3D model

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie

Dresden, Saxony, Germany

Leipzig University, Department of Urology

Leipzig, Saxony, Germany

Universitätsklinikum Bonn, Klinik und Poliklinik für Urologie und Kinderurologie

Bonn, Germany

Outcomes

Primary Outcomes

Primary endpoint is the console operation time measured intra-op.

Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.

Time frame: intra-operative

Secondary Outcomes

Pre-operative - PRA-D

Quality of the Physician-Patient Relationship - Evaluation of the German Version of the Patient Reactions Assessment (PRA-D); fifteen items with seven expressions from "I do not agree at all" to "I agree completely"