A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer

This study has been terminated.
(Principal Investigator Request)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01321697
First received: March 22, 2011
Last updated: August 23, 2013
Last verified: August 2013
Results First Received: June 10, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Vulvar Cancer
Intervention: Procedure: Routine Leg edema and groin dissection

  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
No text entered.

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
Vulvar Cancer Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.

Participant Flow:   Overall Study
    Vulvar Cancer  
STARTED     7  
COMPLETED     0  
NOT COMPLETED     7  
Study Terminated                 7  



  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.
No text entered.

Reporting Groups
  Description
Vulvar Cancer Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.

Baseline Measures
    Vulvar Cancer  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     4  
Gender  
[units: participants]
 
Female     7  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures

1.  Primary:   Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.   [ Time Frame: at time of surgery ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Early termination of the study due to investigator decision. No subjects were analyzed.  


Results Point of Contact:  
Name/Title: Sandy Annis
Organization: University of Arkansas for Medical Sciences
phone: 5016868274
e-mail: amannis@uams.edu


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01321697     History of Changes
Other Study ID Numbers: 110583
Study First Received: March 22, 2011
Results First Received: June 10, 2013
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board