RESUMEN
The latest generation Da Vinci® Xi™ Surgical System Robot released has not been evaluated to date in transoral surgery for head and neck cancers. We report here the 1-year results of a non-randomized phase II multicentric prospective trial aimed at assessing its feasibility and technical specificities. Our primary objective was to evaluate the feasibility of transoral robotic surgery using the da Vinci® Xi™ Surgical System Robot. The secondary objective was to assess peroperative outcomes. Twenty-seven patients, mean age 62.7 years, were included between May 2015 and June 2016 with tumors affecting the following sites: oropharynx (n = 21), larynx (n = 4), hypopharynx (n = 1), parapharyngeal space (n = 1). Eighteen patients were included for primary treatment, three for a local recurrence, and six for cancer in a previously irradiated field. Three were reconstructed with a FAMM flap and 6 with a free ALT flap. The mean docking time was 12 min. "Chopsticking" of surgical instruments was very rare. During hospitalization following surgery, 3 patients experienced significant bleeding between day 8 and 9 that required surgical transoral hemostasis (n = 1) or endovascular embolization (n = 2). Transoral robotic surgery using the da Vinci® Xi™ Surgical System Robot proved feasible with technological improvements compared to previous generation surgical system robots and with a similar postoperative course. Further technological progress is expected to be of significant benefit to the patients.