EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes : the EXPRESsO Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
研究概览
简要总结
Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction. Within this reconstructive paradigm, surgeons may employ two distinct strategies:
(i) immediate reconstruction using a direct-to-implant approach (DTI), or (ii) a two-stage reconstruction consisting of tissue expander placement followed by definitive implant insertion (TE-I).
Each approach is associated with specific indications, advantages, and inherent limitations.
The EXPRESSO study aims to retrospectively compare surgical outcomes between pre-pectoral DTI and TE-I breast reconstruction. By providing real-world evidence on these reconstructive strategies, this study seeks to inform surgical decision-making and to optimize reconstructive outcomes in contemporary breast cancer care.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥18 years
- •Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer
- •Patients undergoing pre-pectoral implant-based breast reconstruction, either:
- •One-stage DTI, or
- •Two-stage TE-I
- •Use of implant with or without biological or synthetic mesh
- •Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side
排除标准
- •Male patients
- •Subpectoral implant-based reconstruction
- •Autologous breast reconstruction
- •Delayed reconstructions not performed at the time of mastectomy
- •Incomplete clinical or follow-up data for primary endpoint analysis
研究者
Rosa Di Micco, MD
MD, PhD
IRCCS San Raffaele