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Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00963859
First received: August 19, 2009
Last updated: April 10, 2013
Last verified: April 2013
Results First Received: June 28, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Intervention: Procedure: Robotic-assisted laparoscopic surgery

  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
Recruitment Period: October 10, 2007 to December 07, 2009; All recruitment done in a medical clinic setting.

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
Robotic-assisted Laparoscopic Surgery Robotic-assisted laparoscopic extended pelvic lymph node dissection

Participant Flow:   Overall Study
    Robotic-assisted Laparoscopic Surgery  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  



  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
Robotic-assisted Laparoscopic Surgery Robotic-assisted laparoscopic extended pelvic lymph node dissection

Baseline Measures
    Robotic-assisted Laparoscopic Surgery  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Median ( Full Range )
  73  
  ( 40 to 82 )  
Gender  
[units: participants]
 
Female     0  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
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1.  Primary:   Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved   [ Time Frame: 3 months including surgery and post-operative period. ]

2.  Primary:   Overall Percentage Median Yield   [ Time Frame: 3 months including surgery and post-operative period. ]


  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: John W. Davis, MD / Assistant Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00963859     History of Changes
Other Study ID Numbers: 2007-0441
Study First Received: August 19, 2009
Results First Received: June 28, 2012
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board