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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The results that follow prove the fundamental feasibility of an NC drill for surgery of the petrosal bone using the example of the simple mastoidectomy in the laboratory test. When using NC, tissue resection is faster, more precise, and has fewer related complications than the same procedure without. The results offer a very promising basis for the introduction of a newly conceived system to the procedure of NC surgery on the petrosal bone. The device configuration used here was originally conceived for NC guidance of a shaver in functional endoscopic sinus surgery. Individual errors will have to be mitigated through the new version of the control unit presently in development.

The implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.