Transoral robotic surgery: A multicenter study to assess feasibility, safety, and surgical margins§

Authors

  • Gregory S. Weinstein MD, FACS,

    1. Department of Otorhinolaryngology–Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania
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    • Gregory S. Weinstein, MD, and Bert W. O'Malley Jr., MD, contributed equally as first authors.

  • Bert W. O'Malley Jr. MD, FACS,

    1. Department of Otorhinolaryngology–Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania
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    • Gregory S. Weinstein, MD, and Bert W. O'Malley Jr., MD, contributed equally as first authors.

  • J. Scott Magnuson MD, FACS,

    1. Department of Otolaryngology–Head and Neck Surgery, University of Alabama-Birmingham, Birmingham, Alabama
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  • William R. Carroll MD,

    1. Department of Otolaryngology–Head and Neck Surgery, University of Alabama-Birmingham, Birmingham, Alabama
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  • Kerry D. Olsen MD, FACS,

    1. Department of Otolaryngology–Head and Neck Surgery, Mayo Clinic, Rochester, Minnesota
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  • Lixia Daio PhD,

    1. Department of Bioinformatics and Computational Biology, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A.
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  • Eric J. Moore MD, FACS,

    1. Department of Otolaryngology–Head and Neck Surgery, Mayo Clinic, Rochester, Minnesota
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  • F. Christopher Holsinger MD, FACS

    Corresponding author
    1. Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A.
    • Department of Head & Neck Surgery, Unit 1445, University of Texas MD Anderson Cancer Center P.O. Box 301402, Houston, TX 77230-1402
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  • 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.

Abstract

Objectives/Hypothesis:

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.

Study Design:

Pooled Data from Independent Prospective Clinical Trials.

Methods:

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.

Results:

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.

Conclusions:

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.

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