Prospective study of the application of a 3D exoscope system (VITOM 3D) in ear surgery compared to conventional surgical microscopes: part I - analysis of objective parameters.

Background: This prospective study compared the application of a 3D exoscope (VITOM 3D) with surgical microscopes (SM) in ear surgery.

Methods: 62 patients were included (exoscope group (E+) n = 31; SM group (E-) n = 31). Procedures included cochlea implantation (nE + = 10, nE- = 10), reconstructive middle ear surgery due to chronic otitis media with (COMwC; nE + = 11, nE- = 11) and without cholesteatoma (COMsC; nE + = 10, nE- = 10). Objective (e.g. set-up time and wrap-up time, corrected cut-suture-time, pure operating time, adjustment time, time per adjustment procedure, learning curves) and subjective perioperative parameters were evaluated. This paper only addressed the analysis of the objective parameters.

Results: The pooled data showed that the mean time delay in the E + group was significantly higher compared to the E- group with regard to set-up time and wrap-up time, corrected cut-suture time, adjustment time and time per adjustment procedure. Time delay tended to be higher for pure operating time. In all subgroups of the E + group, the objective time parameters also showed at least a tendency to be prolonged on average compared to the corresponding subgroups in the E- group. The learning curve analysis showed that the E + group (corrected cut suture time for CI surgery, mean time per adjustment procedure across all subgroups) approached the times of the E- group during the course of the study.

Conclusions: Based on the pooled data from the study arms, the exoscope tends to be inferior to the microscope for the objective time parameters evaluated when used in ear surgery. However, due to the small group sizes, no solid conclusions could be drawn regarding the individual surgical procedures. In addition, further studies with a longer observation period are needed to minimize the influence of the learning curve on the results.