Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- major complications
研究概览
简要总结
The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.
详细描述
The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (> 0.5 cm) and vascularity of skin flap after mastectomy.
The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction.
In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.
The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy
- •adequate mastectomy flap in vascularity and thickness
排除标准
- 未提供
结局指标
主要结局
major complications
时间窗: 12months
evaluation of hematoma, infection, flap necrosis, wound dehiscence rate
risk factor
时间窗: 12 months
evaluation of the risk factors correlated to recostruction failure
reconstruction failure
时间窗: 12 months
loss of implant or switch to autologus recosntruction
minor complications
时间窗: 12 months
evaluation of seroma, rippling, casular contracture, asymmetry rate
次要结局
- patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes(12 months)
- postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes(12 months)