NCT02792322

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oropharyngeal Neoplasms
• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device	Patient's will be having TORS surgery in a seated position

Timeline

• Start date: 2016-07-11
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2016-06-07
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States