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Comparative Study
. 2025 Mar;282(3):1217-1230.
doi: 10.1007/s00405-024-09018-9. Epub 2024 Oct 15.

Conventional one-handed compared to two-handed endoscopic ear surgery using an endoscope holder: a single center study

Affiliations
Comparative Study

Conventional one-handed compared to two-handed endoscopic ear surgery using an endoscope holder: a single center study

Christoph Müller et al. Eur Arch Otorhinolaryngol. 2025 Mar.

Abstract

Introduction: One-handedness is a challenge in conventional endoscopic ear surgery (EES). We present results on the first-ever application of the passive endoscope holder 'Endofix exo' (Co. AKTORmed GmbH, Neutraubling, Germany) in EES, which enables two-handed surgery.

Methods: This two-sided study compares cut-suture time, operating time, postoperative complications, graft take rates, hearing results and quality of life in patients who underwent first stage tympanoplasty due to tympanic membrane perforation with intact ossicular chain conditions. 25 patients received classic EES (EES-, mean age: 28 ± 21 years) and 15 received EES with the passive holder (EES+, mean age: 48 ± 21 years).

Results: Mean operating times (EES-: 96 ± 38 (SD) min; EES+: 107 ± 33 min), cut-suture times (EES-: 68 ± 30 min; EES+: 73 ± 31 min), complications, graft take rates and hearing results (preoperative air bone gap (ABG) (PTA4): 15 dB ± SD 8 dB (EES-); 16 dB ± SD 8 dB (EES+); postoperative ABG (PTA4): 11.25dB ± SD 11.3dB (EES-); 14 dB ± SD 10 dB (EES+)) did not differ significantly (p > 0.05) between the two groups. Postoperative hearing results and quality of life tended to improve in both groups (p > 0.05).

Discussion: The passive endoscope holder has been successfully applied during the course of the study. However, modifications of the endoscope holder and further studies are recommended focusing on positioning of grafts and prostheses to obtain conclusive results regarding the superiority of two-handed EES over one-handed conventional EES.

Keywords: Cut-suture time; Passive endoscope holder; Postoperative outcome; Surgical assistance system; Two-handed endoscopic ear surgery.

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Conflict of interest statement

Financial disclosures/conflicts of interest: There are no financial disclosures or conflicts of interest. Approval of local ethics committee: The study followed the review and approval of the local ethics committee at the Technische Universität Dresden (BO-EK-4012022). Disclosure of potential conflicts of interest: The authors disclose that no conflicts of interest (financial or nonfinancial) occurred in the course of the study and the preparation of this paper. Research involving human participants/informed consent: The study was conducted in accordance with the Declaration of Helsinki and according to the rules of good clinical practice, following the review and approval of the local ethics committee at the Technische Universität Dresden (BO-EK-4012022).

Figures

Fig. 1
Fig. 1
A Absolute and relative distribution of TM defect sizes. TM defects of smaller size (< 1 or 1 quadrant) are predominant in both study arms (EES- and EES+). B Absolute and relative distribution of TM defect localizations. In both study arms, anterior perforations predominate over posterior and central perforations. C TM defect size and applied reconstruction material used. In the EES- arm, the proportion of cartilage and perichondrium or combination grafts increases with the defect size compared to the use of fascia alone; in the EES + arm, fascia is used almost exclusively. D TM defect localization and reconstruction material used. In the EES- arm, the use of cartilage and perichondrium dominates in all defect localizations. In the EES + arm, cartilage and perichondrium are increasingly used for posterior perforations, while fascia dominates in all other perforation localizations
Fig. 2
Fig. 2
A Cut suture time, operating time and difference (operating times – cut-suture times) displayed for both study arms (EES- and EES+). There are no significant differences between the groups. B Subgroup analysis of cut-suture times according to surgeon experience (see explanation regarding the EES + subgroup in the continuous text). C Learning curves: cut-suture times as a function of surgical expertise over time. The EES- and EES + resident subgroups tended to show a clearer decrease in cut-suture times over the course of the study than the subgroups of experienced surgeons
Fig. 3
Fig. 3
A Postoperative survey on surgeon satisfaction with the applied system (EES- or EES+). In the EES + group, satisfaction regarding the items ‘blockage’ and ‘handling’ was statistically significantly worse than in the EES- group. Asterisc (*) indicates statistical significant differences between the study arms. B Comparison of differenct visualisation systems (microscope vs. endoscope (EES-) vs. endoscope + Endofix exo (EES+)) regarding the items ‘handling’, ‘visual display’ and ‘ergonomics’. Statistically significant advantage in favour of EES- over EES + regarding the item ‘handling’ and in favour of microscope over endoscope regarding the item ‘ergonomics’. Asterisc (*) indicates statistical significant difference from reference line
Fig. 4
Fig. 4
A Pre- and postoperative hearing loss (AC, BC and ABG each as PTA4) for both study arms (EES- and EES+). No statistical significant differences between the ams across all items. Tendentially higher mean preoperative and postoperative hearing loss (BC and AC) in the EES + group. B Difference between post- and preoperative hearing loss (AC, BC and ABG each as PTA4) for both study arms. No statistical differences between the two arms, mean results tended to be superior in the EES- arm
Fig. 5
Fig. 5
A Pre- and postoperative HRQOL (ZCMEI 21) for both study arms (EES- and EES+). Higher scores indicated a poorer HRQOL. No statistical significant mean differences between both arms across all items. Tendentially worse preoperative mean HRQOL in the EES + group. B Difference between post- and preoperative HRQOL. No statistical significant differences between both arms across all items. Tendentially superior average HRQOL in the EES + arm except for the item ‘medical ressources’

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