Clinical Trial: A Pilot Study Assessing Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Pilot Study Assessing Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci® Robotic Surgical Systems

Brief Summary: This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

Detailed Summary: The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.
Sponsor: Mayo Clinic

Current Primary Outcome: TORS surgery completion in the seated position [ Time Frame: Measures assessed at time of intervention (during surgery) ]

Recording how many participants' surgery was completed in the seated position


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of participants' surgical time [ Time Frame: Measures assessed at time of intervention (during surgery) ]
    Surgical start and stop times are recorded in the medical record
  • Estimated amount of blood loss during participants' surgery [ Time Frame: Measures assessed at time of intervention (during surgery) ]
    Record blood loss during surgery as estimated by the lead surgeon


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: May 19, 2016
Date Started: May 2016
Date Completion:
Last Updated: June 1, 2016
Last Verified: June 2016