Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Study Overview
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Brief Summary
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To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

Detailed Description
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This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Official Title
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Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Conditions
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Oropharyngeal Cancer, Hypopharyngeal Cancer, Upper Aerodigestive Tract Neoplasms, Head and Neck Cancer

Intervention / Treatment
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* Procedure: da Vinci® Robotic System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and neck lesions requiring surgical resection, biopsy, or invasive treatment; Lesion amendable to robotic assisted surgery treatment; Age > 19 years; Patient must sign informed consent. Exclusion Criteria: Psychological condition that renders the patient unable to understand the informed consent; Poor mouth opening, with maximal opening less than 1.5 cm.

Ages Eligible for Study
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Minimum Age: 20 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: TORS Candidates<br>Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System | Procedure: da Vinci® Robotic System<br>* Head and Neck Surgery using the da Vinci® Robotic System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions | Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions | Intraoperatively average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery. | Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins | 3 - 24 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lesions, Biopsy, Surgery