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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

NCT01406769 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

  • Lymphedema
  • Perioperative/Postoperative Complications
  • Stage IA Vulvar Cancer AJCC v7
  • Stage IB Vulvar Cancer AJCC v7
  • Stage II Vulvar Cancer AJCC v7
  • Stage IIIA Vulvar Cancer AJCC v7
  • Stage IIIB Vulvar Cancer AJCC v7
  • Stage IIIC Vulvar Cancer AJCC v7
  • Stage IVA Vulvar Cancer AJCC v7
  • Stage 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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Jay W Carlson · Gynecologic Oncology Group

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-16
Primary Completion
2020-04-10
Completion
2020-04-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406769 on ClinicalTrials.gov