A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of Vulvar Cancer
- To evaluate the sensitivity, specificity, and feasibility of bioimpedance technology as
compared to clinically derived measurements to include circumferential volumetric
measurements to detect lower-extremity lymphedema in patients who are undergoing an
inguinal lymphadenectomy during the concurrent surgical management of a vulvar cancer.
OUTLINE: This is a multicenter study.
Patients undergo preoperative and postoperative lower-extremity lymphedema assessment
comprising serial circumferential measurements, bioimpedance spectroscopy measurements, and
clinical evaluation using the Stemmer sign.
Patients undergo radical vulvectomy or radical local excision as prescribed by GOG-0244, and
unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy.
After completion of study, patients are followed up at 4-6 weeks, every 3 months for 1 year,
and then every 6 months for 1 year.
Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity, specificity, and feasibility of bioimpedance technology compared to current techniques in measuring lower-extremity lymphedema in patients undergoing surgery for vulvar cancer
Jay W. Carlson, DO
Saint John's Physicians and Clinics
United States: Institutional Review Board, Data Safety and Monitoring Board
|Mercy-Springfield, Cancer Research Ctr. for the Ozarks||Springfield, Missouri 65804|