Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

The University of Alabama at Birmingham

Status: Completed

Conditions: Oropharyngeal Cancer; Upper Aerodigestive Tract Neoplasms; Head and Neck Cancer; Hypopharyngeal Cancer

Treatments: Procedure: da Vinci® Robotic System

Study type: Interventional

Funder types: Other

Identifiers

NCT00473564

F061228004

HNO 0601 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

TORS Candidates

Experimental group

Description:

Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Treatment:

Procedure: da Vinci® Robotic System