Abstract
Objective
The objective of this study is to demonstrate the feasibility and safety of establishing a transoral robotic surgical (TORS) program in the post–Food and Drug Administration (FDA) approval setting. Early outcomes are compared with the previously reported results of pioneering centers.
Study Design
Clinical data from a prospective TORS study.
Setting
Academic university institution.
Subjects and Methods
Sixty-one patients treated with 63 TORS procedures. Main outcome measures: intraoperative times, margin status, complications, time to diet, and percutaneous endoscopic gastrostomy (PEG) tube retention rate. The authors also report oncologic outcomes on their first 30 patients.
Results
The spectrum of subsites included tongue base, tonsil, parapharyngeal space, retromolar trigone, supraglottis, and posterior pharyngeal wall. Surgical console time averaged 79 ± 53 minutes. After re-resection of 4 patients, final negative margin status was 94% (50/53). A subset of 30 patients with squamous cell carcinoma reaching an average of 18 months of follow-up had a local regional control rate of 97% with a disease-free survival rate of 90%. The PEG tube retention rate was 7%. Complications included 2 readmissions with dehydration, 1 aspiration pneumonia, and 2 with minor oropharyngeal bleeding. Ninety-one percent of patients resumed an oral diet by the first postoperative visit.
Conclusion
The initiation of a TORS program in the post-FDA setting can be achieved in a safe and efficient manner. Early results of pioneering TORS centers are reproducible. Continued investigation of TORS as a treatment option for oropharygneal carcinoma is warranted.
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