Clinical Trials Directory

Trials / Completed

CompletedNCT01406769

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

A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of a Vulvar Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies 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. Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBioelectric Impedance AnalysisUndergo preoperative and postoperative lower-extremity lymphedema assessment
PROCEDURELymphadenectomyUndergo lymphadenectomy
PROCEDURETherapeutic Conventional SurgeryUndergo radical vulvectomy or radical local excision

Timeline

Start date
2012-07-16
Primary completion
2020-04-10
Completion
2020-04-10
First posted
2011-08-01
Last updated
2021-05-07

Locations

11 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01406769. Inclusion in this directory is not an endorsement.