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SAGES TAVAC safety and effectiveness analysis: da Vinci® Surgical System (Intuitive Surgical, Sunnyvale, CA)

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Abstract

Background

The da Vinci® Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. There are substantial numbers of peer-reviewed papers regarding the da Vinci® Surgical System, and a thoughtful assessment of evidence framed by clinical opinion is warranted.

Methods

The SAGES da Vinci® TAVAC sub-committee performed a literature review of the da Vinci® Surgical System regarding gastrointestinal surgery. Conclusions by the sub-committee were vetted by the SAGES TAVAC Committee and SAGES Executive Board. Following revisions, the document was evaluated by the TAVAC Committee and Executive Board again for final approval.

Results

Several conclusions were drawn based on expert opinion organized by safety, efficacy, and cost for robotic foregut, bariatric, hepatobiliary/pancreatic, colorectal surgery, and single-incision cholecystectomy.

Conclusions

Gastrointestinal surgery with the da Vinci® Surgical System is safe and comparable, but not superior to standard laparoscopic approaches. Although clinically acceptable, its use may be costly for select gastrointestinal procedures. Current data are limited to the da Vinci® Surgical System; further analyses are needed.

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Authors and Affiliations

  1. Department of Surgery, University of Nevada School of Medicine, 1701 W. Charleston Blvd. Suite 400, Las Vegas, NV, 89102, USA

    Shawn Tsuda

  2. Department of Surgery, University of Nebraska Medical Center, Omaha, NE, USA

    Dmitry Oleynikov

  3. Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA

    Jon Gould

  4. Department of Surgery, Stanford School of Medicine, Stanford, CA, USA

    Dan Azagury

  5. Department of Surgery, University of California San Diego School of Medicine, La Jolla, CA, USA

    Bryan Sandler

  6. Department of Surgery, Harvard Medical School, Boston, MA, USA

    Matthew Hutter

  7. Department of Surgery, Florida Hospital, Orlando, FL, USA

    Sharona Ross

  8. Department of Surgery, University of Texas Medical School at Houston, Houston, TX, USA

    Eric Haas

  9. Department of Surgery, George Washington University, Washington, DC, USA

    Fred Brody

  10. Department of Surgery, University of Washington, Seattle, WA, USA

    Richard Satava

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  1. Shawn Tsuda
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  2. Dmitry Oleynikov
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  3. Jon Gould
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  4. Dan Azagury
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  7. Sharona Ross
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  8. Eric Haas
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  9. Fred Brody
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  10. Richard Satava
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Correspondence to Shawn Tsuda.

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Disclosures

Dr. Brody is a consultant for Covidien, ViiNetwork, Medtronic, Ethicon, and Cooper Surgical. Dr. Gould is on the advisory committee for Torax Medical. Dr. Oleynikov is a board member for Vitrual Incision Corporation and receives research grant from LifeCell Corporation. Dr. Ross is a speaker for Olympus and consultant for Covidien. Dr. Sandler is a speaker for Bard-Davol, Inc. and Ethicon, Inc., and is a consultant for ValenTx, Inc. Dr. Satava receives a research grant from Institute of Surgical Excellence, and is a consultant for Kingdom of Saudi Arabia—Minister of Health and InTouch. Dr. Tsuda is a proctor for Intuitive Surgical and is a speaker for Acelity. Dr. Azagury, Dr. Haas, and Dr. Hutter have nothing to disclose.

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Tsuda, S., Oleynikov, D., Gould, J. et al. SAGES TAVAC safety and effectiveness analysis: da Vinci® Surgical System (Intuitive Surgical, Sunnyvale, CA). Surg Endosc 29, 2873–2884 (2015). https://doi.org/10.1007/s00464-015-4428-y

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  • DOI: https://doi.org/10.1007/s00464-015-4428-y

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