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

Study Overview
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Brief Summary
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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 Description
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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 laryngopharynx is usually preferred to traditional open resection because of the decrease in morbidity and improved functional outcomes experienced by patients. The limiting step in these procedures has been exposure of, visualization of, and access to candidate tumors. The da Vinci surgical system offers the possibility of significant improvements in exposure, visualization and access to these candidate tumors with no added risk to patients. Overall this may significantly increase the number of patients who are candidates for endoscopic surgery. Alternative procedures will include traditional open surgical removal of tumors as well as traditional endoscopic removal of tumors using the microscope and CO2 laser. Open surgical approaches are reserved for patients who have large tumors unsuitable for endoscopic removal or in whom endoscopic visualization of the tumor is inadequate or impossible. The da Vinci surgical system would offer improved visualization of tumors that might otherwise be inaccessible to a traditional endoscopic approach. Candidate patients will present with a neoplasm of the oropharynx, hypopharynx or larynx. Those patients assessed preoperatively to be candidates for transoral surgery (eg, Mallampati class I or II, normal range of neck motion, no trismus) will undergo surgery via a transoral approach to resect the tumor. This will require general anesthesia and may require postoperative hospitalization. If the tumor can be accessed, resection will proceed using the da Vinci robot. In whom the tumor cannot be accessed, resection will proceed via the conventional open approach. Pre and postoperative care will not be affected by this protocol, as it deals strictly with the manner in which the tumor is removed. Postoperative care and visits are standardized as to the nature of the tumor (eg, malignant tumors usually require follow-up visits every four to six weeks to monitor for tumor recurrence). Complications, blood loss, operative time, length of hospitalization, time to resumption of oral intake, time to decannulation, and overall local control rates will be assessed in the postoperative period.

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

Conditions
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Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Head and Neck Cancers

Intervention / Treatment
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* Device: da Vinci Surgical Robot Platform
* Procedure: Transoral Robotic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or volunteer is 18 years of age or older Patients must have indication for diagnosis and/or therapy of diseases of the oropharynx, hypopharynx, and/or larynx. Exclusion Criteria: unexplained fever and/or untreated active infection pregnancy anatomic parameters which preclude transoral surgery, such as: trismus limited range of neck motion poor dentition redundant hypopharyngeal or supraglottic tissue which would prevent adequate visualization of the tumor participation in a research protocol which precludes participation in other protocols

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transoral Robotic Surgery<br>Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. | Device: da Vinci Surgical Robot Platform<br>* daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.<br>Procedure: Transoral Robotic Surgery<br>* Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Complication Rate (Intraoperative and Postoperative) | Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery. | Six weeks | 

Secondary Outcome Measures

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