Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mean operative time
研究概览
简要总结
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
详细描述
Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.
Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.
This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction.
- •Performance statusECOG Performance status ≤ 2
- •Subjects must have normal organ and marrow function as defined below:
- •Hemoglobin ≥ 10.0 g/dl
- •Leukocytes ≥ 3,000/mcL
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelet count ≥ 100,000/mcL
- •Total bilirubin within normal institutional limits
- •AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- •ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- •Serum Creatinine within normal institutional limits
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast.
- •Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued.
- •Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.
结局指标
主要结局
Mean operative time
时间窗: Up to 6 months after reconstruction
Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
Mean dissection time
时间窗: Up to 6 months after reconstruction
Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
次要结局
- Aesthetic outcomes as measured by the Harris scale(Up to 1 year after reconstruction)
- Donor site complications(Up to 1 year after reconstruction)
- Incidence of fat necrosis as measured by a grading system(1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction.)
- Patient satisfaction as measured by BREAST-Q scores(Up to 1 year after reconstruction)