Clinical validation of 4K three-dimensional exoscope system in stapedotomy: a retrospective cohort study.

PURPOSE: To evaluate the technical feasibility and ergonomic advantages of 4K three-dimensional exoscope systems (4K3D-ES) versus operative microscope (OM) in stapedotomy.

METHODS

A retrospective cohort analysis compared 140 consecutive stapedotomy procedures performed by two senior surgeons (4K3D-ES: n = 52 by Surgeon PD; OM: n = 88 by Surgeon DYH) at a tertiary referral center. Outcome measures included operative time (total/procedural phases), intraoperative blood loss, pre- and postoperative audiometric results, complication rates, and ergonomics and image quality of operators were evaluated via a questionnaire.

RESULTS

The 4K3D-ES system demonstrated technical feasibility across all stapedotomy procedures, achieving complete procedural success without intraoperative conversion to OM. Analysis of surgical efficiency metrics revealed statistically comparable performance between the two groups: total operative duration showed no significant difference (p = 0.204), paralleled by equivalent intraoperative blood loss (p = 0.075). Critical procedural phases-including time of exposing the footplate (p = 0.05), footplate fenestration and prosthesis placement phases (p = 0.207)-showed no significant differences. Pre- and postoperative audiological results proved clinically equivalent, with both cohorts achieving substantial air-bone gap improvement while demonstrating comparable closure ABG (p = 0.077). The safety profile proved excellent, with complete absence of major complications such as sensorineural hearing loss, facial nerve or chorda tympani nerve injury. Transient vestibular symptoms occurred in minimal cases (4K3D-ES:2; OM:1), while longitudinal follow-up revealed no delayed complications. Surgical teams' evaluations substantiated the 4K3D-ES's clinical utility through unanimous controllability endorsement, predominant stereoscopic image approval, and widespread ergonomic comfort recognition.

CONCLUSION

4K3D-ES demonstrates technical equivalence to OM while offering superior ergonomics and team-shared 3D visualization, establishing its viability for precision stapes surgery.