Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Not Applicable

Completed

• Conditions: Oropharyngeal Cancer; Upper Aerodigestive Tract Neoplasms; Hypopharyngeal Cancer; Head and Neck Cancer
• Interventions: Procedure: da Vinci® Robotic System

• Registration Number: NCT00473564
• Lead Sponsor: University of Alabama at Birmingham

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Primary Completion: 2013-12
• Results First Submitted: 2015-04-14
• Results First Submitted QC: 2015-04-14
• Results First Posted: 2015-04-30
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TORS Candidates	da Vinci® Robotic System	Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions	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 Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

University of Alabama at Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States