International Prospective REgistry on Pre-pectorAl Breast REconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,236
- 试验地点
- 16
- 主要终点
- Number of patients with Implant-loss at three months postoperatively
研究概览
简要总结
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
详细描述
1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 18 years old
- •Signed informed consent form
- •Patients undergoing mono or bilateral therapeutic mastectomy
- •Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh
排除标准
- •Male patients
- •Patients not suitable for surgical treatment
- •Patients undergoing subpectoral reconstruction
- •Patients undergoing breast reconstruction with autologous tissue.
结局指标
主要结局
Number of patients with Implant-loss at three months postoperatively
时间窗: three months postoperatively
Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
次要结局
- Number of Early onset complication(three months postoperatively)
- Number of late-onset complications(6-12-24 months)
- Number of patients with Infection(three months postoperatively)
- Number of patients with re-admission and re-operation(three months postoperatively)
- Evaluation of Quality of life(0, 6, 12 and 24 months)
研究者
Oreste Davide Gentilini
Professor, Head of Breast Surgery Unit
IRCCS San Raffaele