German Clinical Trials Register

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Brief summary in lay language

The surgical removal of malignant liver lesions is in most cases the only curative treatment. Liver surgery aims to safely remove all affected tissue while minimizing the extent of the resection and loss of functional tissue. To achieve this complex operative interventions in the liver require accurate imaging and visualization of pathological lesions and the operating field. Sectional imaging (e.g. computed tomography and magnetic resonance imaging) is one of the most helpful tools, which aids the surgeon in preparing for the operation, carrying out measurements, visualizing the individual anatomy of the patient, assessing specific risks, taking surgical decisions and thinking through certain operational steps in advance. At the moment radiological imaging data is displayed in stacked sectional views on a standard monitor. The fusion of anatomy, anomalies and pathological changes is solely dependent on the capacity for remembering and the spatial imagination of the operating surgeon. Modern methods allow for a better, immersive and intuitive visualization of all relevant information (patient information, 3D-model of the organs and radiological imaging data) in a virtual reality environment. Particularly the three-dimensional visualization of imaging data is more intuitive. 3D-operation-planning in comparison to traditional 2D-methods proved beneficial in complex liver resection with big central tumors. So far these 3D-models are displayed on 2D-monitors. The present study will evaluate a system which can visualize the operating field of a patient in a three-dimensional, interactive, intuitive and immersive fashion with a head-mounted display (e.g. Oculus Rift™ (Oculus VR® LLC, Irvine, CA, USA). For this patient specific radiological imaging data (computed tomography or magnetic resonance imaging) will be used to create a 3D-model and integrated into a virtual reality environment with a virtual-reality (VR) headset. The operating field can be visualized realistically. In this study we will evaluate to what extent medical students and surgeons, using this technology in comparison to traditional methods, can quickly and correctly identify patient individual anatomy and pathology and make a surgical decision. Participants are medical students or surgeons of the University of Heidelberg. These will use and evaluate three different operation planning methods for complex liver cases in three groups. Traditional operation planning with sectional views on the monitor will be compared to a 3D-visualization on a monitor and a 3D-visualization in a virtual reality environment with VR-headsets. The correctness and speed of surgical decisions with each of the visualization methods will be evaluated. Furthermore satisfaction, usefulness and potential of the visualization methods will be assessed.

Brief summary in scientific language

Liver resection is the best and in most cases definitive treatment for malignant hepatic lesions. Liver surgery aims to safely remove all affected tissue while minimizing the extent of the resection and loss of functional tissue. To achieve this complex operative interventions in the liver require accurate imaging and visualization of the pathology and the operating field. Sectional imaging (e.g. computed tomography and magnetic resonance imaging) is one of the most helpful tools, which aids the surgeon in preparing for the operation, carrying out measurements, visualizing the individual anatomy of the patient, assessing specific risks, taking surgical decisions and thinking through certain operational steps in advance. At the moment radiological imaging data is displayed in stacked sectional views on a standard monitor. Modern methods allow for a better immersive and intuitive visualization of all relevant information (patient information, 3D-model of the organs and radiological imaging data) in a virtual reality environment. Particularly the three-dimensional visualization of imaging data is more intuitive. For this CT-images are segmented and visualized as 3D-models. 3D operation planning in comparison to traditional 2D-methods proved beneficial in complex liver resection with big central tumors in aiding to localize the tumor and planning the resection plane. So far these 3D-models are displayed on 2D-monitors. The present study will evaluate a system which can visualize target structures and the operating field of a patient in a three-dimensional, interactive, intuitive and immersive fashion with a head-mounted display (e.g. Oculus Rift™ (Oculus VR® LLC, Irvine, CA, USA)). For this patient specific radiological imaging data (CT- or MRI-data) will be used to create a 3D-model and integrated into a virtual reality environment with a virtual-reality (VR) headset. The operating field can be visualized realistically. In this study we will evaluate to what extent medical students and surgeons, using this technology in comparison to traditional methods, can quickly and correctly identify patient individual anatomy and pathology and make a surgical decision. This is a prospective, monocentric, randomized controlled study. The participants are medical students and surgeon of the University of Heidelberg. Medical students must have completed the surgical educational module within the medical curriculum of Heidelberg. Participants are stratified according to level of education (students, surgeons) and randomized in one of three arms in a 1:1:1 ratio. Operation planning will be performed either with sectional views on a standard monitor (group “2D, control group), with 3D-models on a standard monitor (group “3D”) or within a virtual reality environment (group “VR). All participants will evaluate three consecutive liver cases with increasing difficulty. A score is determined from the correctness of the answers on an 11-item-checklist assessing liver anatomy and pathology, anomalies and the relation between pathology and anatomy, as well as whether the correct liver resection can be indicated. The time to answer this checklist will be measured. After all liver cases have been evaluated a 14-item-checklist will be filled out assessing satisfaction, usefulness and potential of the visualization methods. All participants receive a standardized recapitulation of liver and vessel anatomy, as well as surgical treatment Options before randomization. After the randomization participants had ample time to familiarize themselves with their visualization method.