Early Detection of Lymphedema With Bio-Electrical Impedance Analysis in Patients After Breast Cancer Surgery
NCT02748746 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-06-04
Summary
Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective methods in clinical usage to detect lymphedema in early stage. The aim of this study is to reveal comparative relation these two methods on detecting lymphedema in an early stage.The another aim of this study is to determine impedance ratios and lymphedema index (L-dex) by using bio-electrical impedance analysis in patients after breast cancer surgery.
Conditions
- Lymphedema
- Breast Cancer
Interventions
- DEVICE
-
Bio Impedance Analysis Measurement
Self-adhesive electrodes will be placed to related side's hand dorsum and foot dorsum regarding to calculate for left or right upper extremity's impedance. After completing the measurements for each side, results will be saved by device and documented on paper. A patient total measurement time lasts approximately 3 minutes.
- DEVICE
-
Tissue Dielectric Constant Measurement
In this study, TDC device (Moisture Meter-D compact-MMDc will be implemented to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. A gentle pressure must required to have accurate sub-tissue fluid percent. Triplicate measurements will be done and taken those average value for each point in order to reach sensitive screening. Computer software simultaneously save these measurements results automatically. A patient total measurement time approximately lasts 5 minutes.
Sponsors & Collaborators
-
The Scientific and Technological Research Council of Turkey
collaborator OTHER -
Abant Izzet Baysal University
lead OTHER
Principal Investigators
-
Yeşim Bakar, Assoc. Prof · Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
-
Alper Tuğral, Res. Assist · Abant Izzet Baysal University School of Physical Therapy and Rehabilitation
-
Ümmügül Üyetürk, Assoc. Prof · Abant Izzet Baysal University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-08-31
- Primary Completion
- 2019-05-31
- Completion
- 2019-11-30
Countries
- Turkey (Türkiye)
Study Locations
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