PRIMARY OBJECTIVES:
1\. Determine feasibility of collecting measurements of body composition.
SECONDARY OBJECTIVES:
1. Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not.
2. To determine the implications of different measures of body composition on outcomes of breast reconstruction.
3. Compare utility of body composition measurements versus other anthropometric assessments on assessing risk of complications following breast surgery.
OUTLINE: This is a observational study. Participants are assigned to 1 of 2 cohorts and will be follow-up for up to 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy.
2. Age ≥ 18 years.
3. Scheduled to undergo mastectomy with immediate breast reconstruction using a permanent implant, tissue expander, or autologous tissue (e.g. Deep Inferior Epigastric Perforator (DIEP) flap, muscle-sparing Transverse Rectus Abdominis Myocutaneous (msTRAM) flap, Profunda Artery Perforator (PAP) flap).
4. Ability to understand a written informed consent document, and the willingness to sign it.
You may not be if
1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
2. Pregnant or breastfeeding.
3. Patients assigned male at birth.
4. Non-cisgender women.
5. Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator).
6. Patients with prosthetic limbs.
Clareo Health | Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction
