Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

Study Overview
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Brief Summary
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The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Detailed Description
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Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).

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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Head and Neck Neoplasms

Intervention / Treatment
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* Device: Da Vinci Robotic Transoral Robotic Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx) Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation Exclusion Criteria: Unexplained fever and/or untreated, active infection Patient pregnancy Previous head and neck surgery precluding transoral/robotic procedures The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transoral Robotic Surgery (TORS)<br>Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System | Device: Da Vinci Robotic Transoral Robotic Surgical System<br>* (TORS) Da Vinci Robotic Transoral Robotic Surgical System<br>* Other names: (TORS) Da Vinci Robotic Transoral Robotic Surgical System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. | In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis | At time of surgery, lasting up to 3 hours. Assessed for up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation. | At time of surgery, up to 3 hours | 
| Number of Participants With Blood Loss and Complications |  | 6 months | 
| Average Time to Set up and Perform Procedures | This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures. | At time of surgery, up to 3 hours | 
| Number of Correctly Predicted Success of TORS Preoperatively | This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures. | preoperative | 
| QOL | Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome. | 6 months |