Retrospective International Multicenter Study Comparing Polyurethan Versus Non-polyurethan Covered Implants in Immediate Prepectoral Implant-based Breast Reconstruction in the Setting of Postmastectomy Radiotherapy: the PRExRT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- capsular contracture
研究概览
简要总结
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction (IBBR) comparing Polyurethan (PU) and non-PU covered implants.
详细描述
Breast cancer affects 2.6 million women worldwide annually, with surgery as the standard treatment for 95% of cases. Rising mastectomy rates, due to advanced diagnostic tools and patient preferences, make immediate breast reconstruction crucial for improving quality of life for around 650,000 women each year. Prepectoral implant-based breast reconstruction (IBBR) has become a preferred approach due to advancements like synthetic meshes, acellular dermal matrices (ADM), and polyurethane (PU) covered implants, which show promise in reducing complications such as capsular contracture, implant loss, and breast animation deformities. Radiotherapy (RT), however, increases these risks, especially for capsular contracture, underscoring the need for strategies to mitigate such outcomes.
This multicenter retrospective cohort study will investigate the impact of radiotherapy on complications such as capsular contracture and implant loss in patients with breast cancer who underwent mastectomy and prepectoral IBBR. The study will compare outcomes between PU and non-PU covered implants using data from approximately 30 international sites. Patient information will be extracted from hospital records, coded for confidentiality, and analyzed statistically to achieve the study's objectives of improving post-reconstruction outcomes and quality of life for patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 with signed General consent or study specific consent form
- •Patients with confirmed diagnosis of primary or recurrent breast cancer
- •Patients undergoing nipple - or skin-sparing mastectomy with prepectoral IBBR (all types of implants, with or without mesh, all types of biologic and synthetic mesh, one- or two- stage) in the setting of PMRT (or any type or RT before reconstruction) between 2016 and
- •Patients undergoing two-stage IBBR with radiotherapy to the expander before reconstruction with implant.
- •Patients with recurrent breast cancer after breast conserving surgery and radiotherapy.
- •Follow up must be at least 2 years after IBBR.
- •Patients aged 18 and above will be eligible for inclusion.
排除标准
- •Patients who have explicitly refused the further use of their data through a consent declaration.
- •Patients undergoing subpectoral IBBR or autologous reconstruction as initial type of reconstruction.
- •No radiotherapy.
研究组 & 干预措施
PU covered implants
prepectoral IBBR with a PU covered implant followed by radiotherapy
干预措施: Radiotherapy (Procedure)
non-PU covered implants
prepectoral IBBR with a non-PU covered implant followed by radiotherapy
干预措施: Radiotherapy (Procedure)
结局指标
主要结局
capsular contracture
时间窗: 2-6 years post-surgery
capsular contracture rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
次要结局
- implant loss rate(2-6 years post-surgery)
- re-surgery rate(2-6 years post-surgery)
- hematoma rate(2-6 years post-surgery)
- infection rate(2-6 years post-surgery)
- implant exchange rate(2-6 years post-surgery)