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.