Gregory S. Weinstein, MD, and Bert W. O'Malley Jr., MD, contributed equally as first authors.
Head and Neck
Version of Record online: 2 JUL 2012
Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.
Volume 122, Issue 8, pages 1701–1707, August 2012
How to Cite
Weinstein, G. S., O'Malley, B. W., Magnuson, J. S., Carroll, W. R., Olsen, K. D., Daio, L., Moore, E. J. and Holsinger, F. C. (2012), Transoral robotic surgery: A multicenter study to assess feasibility, safety, and surgical margins. The Laryngoscope, 122: 1701–1707. doi: 10.1002/lary.23294
An unrestricted educational grant from Intuitive Surgical, Inc. was received by the University of Pennsylvania and the University of Alabama for data collection during their independently funded clinical trials.
Drs. Weinstein, O'Malley, Holsinger, and Magnuson indicate that they have served as consultants for Intuitive Surgical, Inc. for training courses and educational activities, such as proctoring. None of the authors own stock or receive royalties from Intuitive Surgical, Inc. Drs. Holsinger, Weinstein, and O'Malley have ended their financial relationship with Intuitive Surgical, Inc.
The authors have no other funding, financial relationships, or conflicts of interest to disclose.
- Issue online: 25 JUL 2012
- Version of Record online: 2 JUL 2012
- Manuscript Accepted: 22 FEB 2012
- Manuscript Revised: 27 JAN 2012
- Manuscript Received: 19 NOV 2011
- Transoral robotic surgery;
- oropharyngeal carcinoma;
- head and neck;
- human papilloma virus;
- squamous carcinoma;
- Level of Evidence: B.2; review of independent cohort studies.
Our objective was to determine the safety, feasibility, and the adequacy of surgical margins for transoral robotic surgery (TORS), by reviewing the early results from independent institutional review board-approved clinical trials in three separate institutions.
Pooled Data from Independent Prospective Clinical Trials.
One hundred ninety-two patients were initially screened, but inadequate exposure did not permit TORS in 13 (6.7%). For two additional patients, TORS was begun but intraoperatively converted to an open procedure. Thus, the intent-to-treat population was 177 patients (average age, 59 years; 81% male), predominantly comprised of tumors arising in the oropharynx (139, 78%) and larynx (26, 15%). TORS was performed for 161 (91%) patients with malignant disease: 153 (95%) with squamous cell carcinoma (T1 [50, 32.7%], T2 [74, 48.4%], T3 [21, 13.7%], T4 [8, 5.2%]), six patients (3.72%) with salivary gland tumors, and two patients with carcinoma in situ. The average follow-up was 345 days.
There was no intraoperative mortality or death in the immediate postoperative period. Average estimated blood loss was 83 mL; no patient required transfusion. The rate of positive margins was 4.3%. Twenty-nine patients (16%) experienced 34 serious adverse events that required hospitalization or intervention (grade 3) or were considered life threatening (grade 4, 2.3%). Tracheostomy was performed in 12.4% of all patients (22/177), but only 2.3% had a tracheostomy at last follow-up. For all patients undergoing TORS without previous therapy, the percutaneous endoscopic gastrostomy dependency rate was 5.0%. The average hospital stay was 4.2 days.
Based on this multicenter study, TORS appears to be safe, feasible, and as such play an important role in the multidisciplinary management of head and neck cancer.