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Evaluation of a Navigation System for ENT with Surgical Efficiency Criteria

Authors

  • Gero Strau MD,

    Corresponding author
    1. Federal Ministry of Education and Research (BMBF) Innovation Center Computer Assisted Surgery ICCAS, University of Leipzig, Leipzig, Germany
    • Dr. Gero Strauβ, Innovation Center Computer Assisted Surgery (ICCAS), Klinik und Poliklinik für HNO-Heilkunde/Plastische Operationen, Universität Leipzig, Liebigstraβe 18a, 04103 Leipzig, Germany.; or Dr. Tim Lüth, Lehrstuhl für Mikro- und Medizingerätetechnik, Technische Universität München, Bolzmannstrasse 15, 85748 Garching bei München, Germany
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  • Kirill Koulechov PhD,

    1. Chair for Microscopic Technology and Medical Instrument Technology, Technical University of Munich, Munich, Germany
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  • Stefan Röttger,

    1. Institute for Psychology and Ergonomics (Specialty Industrial and Organizational Psychology FGAO), Technical University of Berlin, Berlin, Germany
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  • Jenny Bahner,

    1. Institute for Psychology and Ergonomics (Specialty Industrial and Organizational Psychology FGAO), Technical University of Berlin, Berlin, Germany
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  • Christos Trantakis MD,

    1. Department for Neurosurgery, University of Leipzig, Leipzig, Germany
    2. Federal Ministry of Education and Research (BMBF) Innovation Center Computer Assisted Surgery ICCAS, University of Leipzig, Leipzig, Germany
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  • Mathias Hofer MD,

    1. Federal Ministry of Education and Research (BMBF) Innovation Center Computer Assisted Surgery ICCAS, University of Leipzig, Leipzig, Germany
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  • Werner Korb BMBF,

    1. Federal Ministry of Education and Research (BMBF) Innovation Center Computer Assisted Surgery ICCAS, University of Leipzig, Leipzig, Germany
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  • Oliver Burgert PhD,

    1. Federal Ministry of Education and Research (BMBF) Innovation Center Computer Assisted Surgery ICCAS, University of Leipzig, Leipzig, Germany
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  • Juergen Meixensberger MD,

    1. Department for Neurosurgery, University of Leipzig, Leipzig, Germany
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  • Dietrich Manzey PhD,

    1. Department for ENT/Plastic Surgery, University of Leipzig, Leipzig, Germany
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  • Andreas Dietz MD, PhD,

    1. Department for ENT/Plastic Surgery, University of Leipzig, Leipzig, Germany
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  • Tim Lüth PhD

    1. Chair for Microscopic Technology and Medical Instrument Technology, Technical University of Munich, Munich, Germany
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  • This study was supported by resources from the European Fund for Regional Development (EFFRE), the Federal Ministry of Education and Research (ICCAS), the Alfried Krupp von Bohlen and Halbach Foundation, and the German Research Foundation (DFG).

Abstract

The aim of this study is the evaluation of a navigation system (NaviBase) for ENT surgery. For this purpose, a new methodology for the evaluation of surgical and ergonomic system properties has been developed. The practicability of the evaluation instruments will be examined using the example of the overall assessment of the system in comparison with the current surgical standard and with other systems using clinical efficiency criteria. The evaluation is based on 102 ENT surgical applications; of these, 89 were functional endoscopic sinus surgeries (FESS). The evaluation of surgical and ergonomic performance factors was performed by seven ENT surgeons. To evaluate surgical system properties, the Level of Quality (LOQ) in 89 cases of the FESS was determined. It compares the existing information of the surgeon with that of the navigation system on a scale of 0 to 100 and with a mean value of 50 and places it in a relationship to the clinical impact. The intraoperative change of the planned surgical strategy (Change of Surgical Strategy) was documented. The ergonomic factors of the system with the categories of Overall Confidence (Trust), awareness of the situation (Situation Awareness), influence on the operating team, requirements for specific skills (Skill Set Requirement), and cognitive load (Workload Shift) were recorded for all surgical procedures as Level of Reliance (LOR). In the evaluation of the surgical system properties, an average evaluation of the quality of the information, as an LOQ of 63.59, resulted. Every second application of the navigation system (47.9%), on average, led to a change in the surgical strategy. An extension/enhancement of the indication of the endonasal approach through the use of the navigation system was shown in 7 of 102 (6.8%) cases. The completion of the resection in the FESS was rated by 74% of group I and 11% of group II as better in comparison with the standard approach. Total confidence shows a positive evaluation of 3.35 in the LOR. To supplement the evaluation of the navigation system, the technical parameters were included. The maximum deviation, Amax, of the displayed position of the reference value amounted to 1.93 mm. The average deviation was at 1.29 mm with an SD above all values, sd, of 0.29. The subsequent economic evaluation resulted in an effective average extra expenditure of time of 1.35 minutes per case. The overall evaluation of the system imparts application-relevant information beyond the technical details and permits comparability between different assistance systems.

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