Intraoperative Indocyanine Green Laser (ICG) Angiography; Evaluation of Postoperative Outcomes for Breast Reconstruction With Autologous Tissue Flaps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 主要终点
- Major complications
研究概览
简要总结
The purpose of this study is to identify and compare complication rates between autologous breast reconstruction techniques with and without the inclusion on intraoperative indocyanine green (ICG) angiography.
详细描述
ICG-angiography is a real-time visualization of tissue perfusion using intravenous fluorescence. It allows the surgeon a tool for intraoperatively assessment of tissue perfusion of the autologous flap, providing a basis for trimming of hypo perfused areas. The study evaluates the effect of inclusion of this technique by examine postoperative outcomes retrospectively. This is done by differentiation between major and minor complications to evaluate the greatest gains of the intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible patients over the age of 18 years
- •Deemed suitable for breast reconstruction with the latissimus dorsi (LD) myocutaneous flap, muscle sparring LD flap or transverse rectus abdominal muscle (TRAM) flap
排除标准
- •Patients with recurrence of breast cancer
- •Smoking 4 weeks prior of operation
- •Not able to read and understand Danish
结局指标
主要结局
Major complications
时间窗: Measured at 6 months followup.
Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma.
次要结局
- Timing of reconstruction(Measured from day 0 with 6 months followup)
- Minor complications(Measured from day 0 with 6 months followup)