Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy

OBJECTIVES:

I. 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.

Inclusion criteria

• Patients with vulvar cancer already enrolled onto Gynecologic Oncology Group (GOG)-0244 who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will receive a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy;

• Patients who are going to receive multi-modality therapy (radiation +/- chemotherapy) after undergoing surgery are eligible
• Patients who have met the pre-entry requirements
• Patients must have signed an approved informed consent and authorization permitting release of personal health information for GOG-0269 and for GOG-0244
• Patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy during the same operative event
• Serum Albumin level of >= 3.0 within 14 days of entry
• Patients with a GOG performance status of 0, 1, or 2

Exclusion criteria

• Patients not enrolled onto GOG-0244
• Patients with any prior clinical history of lower extremity lymphedema
• Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
• Patients with a prior history of chronic lower extremity swelling
• Patients with a GOG Performance Grade of 3 or 4
• Patients with a history of other invasive malignancies if that malignancy included a bilateral lymph node procedure (example: bilateral mastectomies and axillary lymphadenectomies) or if their previous cancer treatment included any of the surgical procedures
• Patients who have had prior lower extremity vascular surgery (arterial or venous)
• Patients who have had prior pelvic bilateral axillary or any pelvic, abdominal, inguinal, or lower extremity radiation therapy
• Patients who are going to receive another elective surgery during the same operative event as their inguinal lymphadenectomy and vulvar surgery
• Patients who undergo sentinel node biopsy without the intention of undergoing a complete lymphadenectomy during that same operative event
• Patients with an implanted cardiac device such as a pacemaker or implantable cardioverter defibrillator
• Patients who are pregnant or currently breastfeeding
• Patients who have been treated for, or are at risk of, bilateral arm lymphedema
• Patients with an allergic reaction to electrocardiogram (EKG) electrodes
• Patients who have had bilateral auxiliary dissection