Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00473564
First received: May 14, 2007
Last updated: April 14, 2015
Last verified: April 2015
Results First Received: April 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Oropharyngeal Cancer
Hypopharyngeal Cancer
Upper Aerodigestive Tract Neoplasms
Intervention: Procedure: da Vinci® Robotic System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TORS Candidates Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Participant Flow:   Overall Study
    TORS Candidates  
STARTED     170  
COMPLETED     147  
NOT COMPLETED     23  
robot surgery aborted in OR                 23  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
TORS Candidates Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Baseline Measures
    TORS Candidates  
Number of Participants  
[units: participants]
  170  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     113  
>=65 years     57  
Gender  
[units: participants]
 
Female     43  
Male     127  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     15  
White     154  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions   [ Time Frame: Intraoperatively ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: William Carroll, MD
Organization: University of Alabama at Birmingham
phone: 205-934-9767
e-mail: wcarroll@uabmc.edu


No publications provided by University of Alabama at Birmingham

Publications automatically indexed to this study:

Responsible Party: William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00473564     History of Changes
Other Study ID Numbers: F061228004, HNO 0601
Study First Received: May 14, 2007
Results First Received: April 14, 2015
Last Updated: April 14, 2015
Health Authority: United States: Institutional Review Board