Breast Cancer, Breast Carcinoma
Conditions
Keywords
Postmastectomy breast reconstruction
Brief summary
This study compares measurements of body composition to outcomes of breast reconstruction.
Detailed description
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.
Interventions
PROCEDUREMeasurement of Body Composition
Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.
OTHERChart Review
Clinical and surgical data will be collected from the participants medical records.
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Body Composition Measurement Collection | up to 2 years | The proportion of enrolled participants with successfully obtained body composition measurements at both preoperative and postoperative timepoints. A success rate of ≥90% will be considered feasible. The proportion of the participants meets feasibility will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Variability of Body Composition | up to 2 years | To investigate how body fat measurements change after surgery and how consistent these measurements are when repeated. |
| Pre- to Postoperative Changes in Body Composition and Their Association with BMI | up to 2 years | Associations between body fat parameters and changes in BMI will be evaluated using correlative analyses. |
| Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction | up to 2 years | The association between body composition parameters and postoperative complications following breast reconstruction will be examined. Complications of interest include infection, seroma, hematoma, delayed wound healing, and tissue necrosis. |
Countries
United States
Contacts
CONTACTMichael Choi
PRINCIPAL_INVESTIGATORMerisas Piper, MD
University of California, San Francisco
Outcome results
None listed