Head and Neck Cancer, Oropharyngeal Neoplasms
Conditions
Keywords
Cancer, Oropharynx
Brief summary
This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® 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
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.
Interventions
DEVICETransoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Patient's will be having TORS surgery in a seated position
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TORS surgery completion in the seated position | Measures assessed at time of intervention (during surgery) | Recording how many participants' surgery was completed in the seated position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of participants' surgical time | Measures assessed at time of intervention (during surgery) | Surgical start and stop times are recorded in the medical record |
| Estimated amount of blood loss during participants' surgery | Measures assessed at time of intervention (during surgery) | Record blood loss during surgery as estimated by the lead surgeon |
Countries
United States
Outcome results
None listed