A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery

Study Overview
=================
Brief Summary
-----------------
Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques. They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.). The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate. Secondary objective include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy. To evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery. 5. Endpoints will be compared to historical controls.

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).22 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
-----------------
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years f age Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck Written informed consent Exclusion Criteria: Unexplained fever and/or untreated, active infection Pregnancy Previous head and neck surgery precluding transoral/endoscopic/robotic procedures Presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>robot assisted endoscopic head and neck surgery | Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System<br>* Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ability to adequately visualize the operative field and complete planned surgery |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate compared to standard endoscopic and minimally invasive procedures |  | 1 month | 
| blood loss compared to historical controls of endoscopic and minimally invasive procedures |  | 1 day | 
| quality of life at early (1-3 months) and late (one year) |  | 1 year | 
| number of days hospitalized immediately after surgery |  | at discharge from hospital | 
| Time to recurrence of tumor or other pathology for which procedure was performed |  | at recurrence of tumor or pathology | 
| Time from start of treatment to death |  | at time of death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robotic, robot assisted, minimally invasive, tumors of head and neck