Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction

PRIMARY OBJECTIVES:

• Determine feasibility of collecting measurements of body composition.

SECONDARY OBJECTIVES:

• Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not.
• To determine the implications of different measures of body composition on outcomes of breast reconstruction.
• 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.

Inclusion criteria

• Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy.
• Age ≥ 18 years.
• 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).
• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

• Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Pregnant or breastfeeding.
• Patients assigned male at birth.
• Non-cisgender women.
• Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator).
• Patients with prosthetic limbs.