Clinical Trial: Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Study Assessing Transoral Robotic Surgery (TORS) For Oral And Laryngopharyngeal Benign And Malignant Lesions Using The da Vinci® Robotic Surgical System

Brief Summary: To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx.

Detailed Summary:

In the past two decades the interest in minimally invasive techniques for transoral treatment of head and neck benign and malignant lesions has been growing due to the decreased morbidity of transoral approaches, and some surgeons have been moving away from traditional open resections. Transoral resection of neoplasms of the upper aerodigestive, by its minimally invasive nature, may afford a shorter hospitalization and recovery time for patients when compared to those patients who undergo traditional "open" surgery. In surgery of the oropharynx, hypopharynx, and larynx, transoral endoscopic surgery can provide similar outcomes in terms of local control of disease when compared to open procedures, while improving time to restoration of oral intake and shortening time to tracheostomy decannulation. Therefore, in select patients, a transoral surgical approach may afford clear advantages over traditional open approaches. Current techniques, however, are limited by the inability to attain direct line of site exposure of the lesion. Use of robot-assisted technology as a means to overcome surgical limitations, to provide surgeons with improved dexterity and precision, and to couple advanced imaging techniques with three-dimensional depth perception, may allow for the completion of transoral surgical approaches in patients for whom conventional technology has been suboptimal.

The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is FDA-approved for use in a variety of laparoscopic, thoracoscopic, cardiac, and urologic surgical procedures. This protocol will assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx. Traditional endoscopic removal of tumors of the oropharynx and laryngopharyn
Sponsor: Stanford University

Current Primary Outcome: Overall Complication Rate (Intraoperative and Postoperative) [ Time Frame: Six weeks ]

Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.


Original Primary Outcome: Overall complication rate (intraoperative and postoperative

Current Secondary Outcome:

  • Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure [ Time Frame: Six weeks ]
  • Average Blood Loss [ Time Frame: Duration of procedure up to two hours ]
    Blood lost during procedure
  • Average Operative Time [ Time Frame: Up to four hours (240 minutes) ]
    Average operative time in minutes


Original Secondary Outcome: Feasibility defined as ability to perform the planned diagnostic or therapeutic procedure, blood loss, intraoperative time.

Information By: Stanford University

Dates:
Date Received: July 22, 2008
Date Started: September 2010
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016