Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Study Overview
Brief Summary
To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.
Detailed Description
This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Head and neck lesions requiring surgical resection, biopsy, or invasive treatment;
- •Lesion amendable to robotic assisted surgery treatment;
- •Age > 19 years;
- •Patient must sign informed consent.
Exclusion Criteria
- •Psychological condition that renders the patient unable to understand the informed consent;
- •Poor mouth opening, with maximal opening less than 1.5 cm.
Arms & Interventions
TORS Candidates
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Intervention: da Vinci® Robotic System (Procedure)
Outcomes
Primary Outcomes
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Time Frame: Intraoperatively average of 2 hours
Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
Secondary Outcomes
- Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.(3 - 24 months postoperatively)
Investigators
William Carroll, MD
Professor of Surgery
University of Alabama at Birmingham