Transoral robotic surgery (TORS) using the da Vinci Xi: prospective analysis of feasibility, safety, and outcomes.

Background: The da Vinci Xi system is not Food and Drug Administration approved for transoral robotic surgery (TORS), resulting in limited data.

Methods: This prospective study evaluates the feasibility, safety, and outcomes of Xi-TORS in an oncological setting.

Results: Sixty-one patients with head and neck cancer were consecutively included for Xi-TORS. Adequate exposure and macroscopically complete resection were achieved in 59 patients (success rate = 96.7%). Intraoperative difficulties and complications were encountered in 47.5% and 20.3% of patients, respectively. Postoperative hemorrhage occurred in 11.9%; no treatment-related deaths were encountered. Two-year overall survival and disease-specific survival were 90.5% and 95.6%, respectively. No long-term (>1 month) tracheotomies were necessary, and only two patients remained tube-feeding dependent. The functional baseline level was regained at 12 months for the MD Anderson Dysphagia Inventory and at 24 months for the Swallowing quality-of-life questionnaire. QLQ-H&N35-assessed QOL returned to baseline 6 months postoperatively.

Conclusions: Xi-TORS is safe, feasible, and with high oncological and functional effectiveness.