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

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 16, 2012

Primary Completion Date

April 10, 2020

Study Completion Date

April 10, 2020

Conditions
LymphedemaPerioperative/Postoperative ComplicationsStage IA Vulvar Cancer AJCC v7Stage IB Vulvar Cancer AJCC v7Stage II Vulvar Cancer AJCC v7Stage IIIA Vulvar Cancer AJCC v7Stage IIIB Vulvar Cancer AJCC v7Stage IIIC Vulvar Cancer AJCC v7Stage IVA Vulvar Cancer AJCC v7Stage IVB Vulvar Cancer AJCC v6 and v7
Interventions
PROCEDURE

Bioelectric Impedance Analysis

Undergo preoperative and postoperative lower-extremity lymphedema assessment

PROCEDURE

Lymphadenectomy

Undergo lymphadenectomy

PROCEDURE

Therapeutic Conventional Surgery

Undergo radical vulvectomy or radical local excision

Trial Locations (11)

43210

Ohio State University Comprehensive Cancer Center, Columbus

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

46260

Saint Vincent Hospital and Health Care Center, Indianapolis

53792

University of Wisconsin Hospital and Clinics, Madison

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

65804

Mercy Hospital Springfield, Springfield

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa

77030

M D Anderson Cancer Center, Houston

89169

Women's Cancer Center of Nevada, Las Vegas

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Gynecologic Oncology Group

NETWORK

NCT01406769 - 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 | Biotech Hunter | Biotech Hunter