Clinical Trial: Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

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 Summary: 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.
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: 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


Original Primary Outcome: Assess exposure and access to oropharyngeal and hypopharyngeal head and neck lesions

Current Secondary Outcome: 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. [ Time Frame: 3 - 24 months postoperatively ]

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


Original Secondary Outcome: Assessment of patient safety and document surgical time and set-up

Information By: University of Alabama at Birmingham

Dates:
Date Received: May 14, 2007
Date Started: February 2007
Date Completion:
Last Updated: February 5, 2016
Last Verified: February 2016