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

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University of Arkansas

Status

Terminated

Conditions

Vulvar Cancer

Treatments

Procedure: Routine Leg edema and groin dissection

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

This will be a non-blinded, non-randomized study to further our knowledge of and experience with lymph node surgery. The investigators are interested in documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone, Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or contralateral groin who have not had prior groin surgery or radiation to the groins. Patients must meet inclusion and exclusion criteria to be enrolled.

Enrollment

7 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients 18-100 years of age.
  • All races and ethnicities.
  • Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar cancer requiring lymph node evaluation for the ipsilateral or contralateral groin.
  • Willing participation following informed consent process.

Exclusion criteria

  • Has not had prior groin surgery or radiation to the groins.
  • Any condition the PI or study physician determines that will put the subject at risk during the procedure.
  • Allergy to blue dye used in lymphatic identification.
  • Pregnant or breast feeding.

Trial design

7 participants in 1 patient group

Vulvar Cancer
Treatment:
Procedure: Routine Leg edema and groin dissection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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