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

Mayo Clinic

Status

Completed

Conditions

Oropharyngeal Neoplasms

Head and Neck Cancer

Treatments

Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device

Study type

Interventional

Funder types

Other

Identifiers

NCT02792322

16-001297

NCI-2022-10968 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.