Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

University of Alabama at Birmingham170 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Head and Neck Cancer Oropharyngeal Cancer Hypopharyngeal Cancer Upper Aerodigestive Tract Neoplasms

Interventions

da Vinci® Robotic SystemPROCEDURE

Head and Neck Surgery using the da Vinci® Robotic System

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions

Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions

Time frame: Intraoperatively average of 2 hours

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.

Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

Time frame: 3 - 24 months postoperatively

Data from ClinicalTrials.gov

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