Abstract

(1) Background: The purpose of this study was to develop an image-guided endoscopic sinus surgery (IGESS) system, named Medigator®, based on the leave-one-out registration strategy and three-dimensional (3D) volumetric visualization of the nasal cavity and paranasal sinuses. (2) Methods: A phantom was designed and fabricated using a 3D printer. We then performed a phantom-based accuracy evaluation to validate the performance of the developed registration method. We included 11 patients who underwent IGESS for clinical study to compare the performance of the developed IGESS system with that of a commercialized system. (3) Results: The fiducial registration error (FRE) was 0.14 mm, and the target registration error (TRE) was 0.82 ± 0.50 mm by the phantom-based evaluation. As a result of the clinical comparative study, the average registration times were 36.04 ± 4.7 and 89.35 ± 26.1 s for the developed and commercialized systems, respectively (p < 0.05). The image loading time of the developed system was also shorter than that of the commercialized system (p < 0.05). The average accuracy score of the developed system was not significantly different from that of the commercialized system (p > 0.05). (4) Conclusions: The developed system provided an accurate point-to-point registration method based on the leave-one-out strategy. According to the results of the clinical comparative study, we demonstrated that the developed system showed reliable potential for clinical application.

Highlights

  • Half of patients with chronic rhinosinusitis undergo surgery within 6 months of their diagnosis [1]

  • Our method provided the slab volume view to the surgeon to accurately recognize the positional relationship between the pointing tool tip and the adjacent anatomical structures of the patient during the surgery (Figure 2)

  • In endoscopic sinus surgery (ESS) in chronic sinusitis patients, an image-guided surgery (IGS) system is considered to be a valuable tool for surgeons to make important decisions during surgery [29]

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Summary

Introduction

Half of patients with chronic rhinosinusitis undergo surgery within 6 months of their diagnosis [1]. Surgeons need a more accurate, technically advanced method to prevent such complications during surgery. Image-guided surgery (IGS) systems have been introduced to provide intuitive perception of the surgical target and adjacent anatomical structures for surgeons. IGS systems require accurate positioning of the surgical instruments or target anatomical structures [2]. Point-to-point registration using a corresponding pair of fiducial markers, such as non-invasive adhesive markers, invasively implanted markers, or anatomical landmarks, is commonly used for IGS systems [9,10,11,12,13,14]. In ESS using an IGS system, point-to-point registration methods use anatomical fiducials on the facial skin of patient [8]. Since there are no systematic criteria for evaluating registration accuracy, researchers have used non-standardized methods to evaluate it

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