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Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473564
First Posted: May 15, 2007
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
Results First Submitted: April 14, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions   [ Time Frame: Intraoperatively average of 2 hours ]

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00473564     History of Changes
Other Study ID Numbers: F061228004
HNO 0601 ( Other Identifier: UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee )
First Submitted: May 14, 2007
First Posted: May 15, 2007
Results First Submitted: April 14, 2015
Results First Posted: April 30, 2015
Last Update Posted: March 8, 2016