Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

Study Overview
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Brief Summary
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This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci&#174; Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

Detailed Description
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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.

Official Title
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A Pilot Study Assessing Robotic Surgery in the Seated or Supine Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical Systems and Modified Transoral Instrumentation

Conditions
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Oropharyngeal Neoplasms, Head and Neck Cancer

Intervention / Treatment
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* Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck. Written informed consent. Pre-Operative Exclusion Criteria: Unexplained fever and/or untreated, active infection. Patient pregnancy. Previous head and neck surgery precluding robotic procedures. The presence of medical conditions contraindicating general anesthesia or standard surgical approaches. Intra-Operative Exclusion Criteria: It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting: Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position. In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trans Oral Robotic Surgery (TORS)<br>Patient's are having TORS surgery in a seated position | Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device<br>* Patient's will be having TORS surgery in a seated position<br>* Other names: Da Vinci Robotic Surgical Systems;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TORS surgery completion in the seated position | Recording how many participants' surgery was completed in the seated position | Measures assessed at time of intervention (during surgery) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oropharynx