Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of Body Composition Measurement Collection
研究概览
简要总结
This study compares measurements of body composition to outcomes of breast reconstruction.
详细描述
PRIMARY OBJECTIVES:
1. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort A: Implant-based Reconstruction
Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.
干预措施: Measurement of Body Composition (Procedure)
Cohort A: Implant-based Reconstruction
Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.
干预措施: Chart Review (Other)
Cohort B: Autologous Reconstruction
Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.
干预措施: Measurement of Body Composition (Procedure)
Cohort B: Autologous Reconstruction
Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.
干预措施: Chart Review (Other)
结局指标
主要结局
Proportion of Body Composition Measurement Collection
时间窗: 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.
次要结局
- Postoperative Variability of Body Composition(up to 2 years)
- Pre- to Postoperative Changes in Body Composition and Their Association with BMI(up to 2 years)
- Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction(up to 2 years)