Retrospective Analysis of Clinical Outcomes and Complication Rates in Patients Undergoing Two-Stage Breast Reconstruction Using Nano- and Microtextured Tissue Expanders With Evaluation of the Impact of Prior Radiotherapy
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Comenius University
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Association Between Expander Surface Type and Complications
概览
简要总结
This retrospective observational study evaluates clinical outcomes and complication rates in women who underwent two-staged implant-based breast reconstruction using tissue expanders and implants following mastectomy for breast cancer. The study focuses on comparing postoperative complications associated with nano- and microtextured tissue expanders and assessing the influence of prior radiotherapy on reconstructive outcomes.
The hypothesis of the study is that the surface characteristics of tissue expanders and a history of radiotherapy may influence the incidence and type of postoperative complications as well as overall reconstructive success.
详细描述
Breast reconstruction represents an integral component of comprehensive breast cancer management, contributing significantly to the physical and psychological well-being of patients following mastectomy. Implant-based two-stage breast reconstruction using tissue expanders remains one of the most commonly performed reconstructive techniques.
This retrospective cohort study analyzes clinical data from women who underwent two stage breast reconstruction with the use of tissue expanders. The primary objective is to evaluate surgical outcomes and complication rates associated with different expander surface characteristics, specifically nano- and microtextured expanders.
Particular attention is given to postoperative complications, including seroma formation, infection, hematoma, capsular contracture, expander rupture, expander rotation, explantation, and subjective perception of breast hardness. Additionally, the study assesses the impact of prior radiotherapy on complication rates and reconstructive outcomes.
The study aims to contribute to the optimisation of reconstructive strategies and expander selection by identifying potential associations between expander surface type, radiotherapy exposure, and clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of mastectomy for breast cancer or prophylactic mastectomy
- •Undergoing two-stage breast reconstruction
- •Reconstruction performed using tissue expanders and implants
- •Availability of complete medical documentation
- •Regular follow-up visits
排除标准
- •Reconstruction using autologous tissue
- •Reconstruction using permanent expander
- •Single-stage Reconstruction using implant
- •Incomplete clinical documentation
- •Missing follow-up data relevant to complication assessment
研究组 & 干预措施
Nanotextured, post-RT
Nanotextured, post-RT -group of radiated breast tissue prior to the nanotextured-expander surgery
Nanotextured, no-RT
Nanotextured, no-RT - group of not-radiated breast tissue prior to the nanotextured-expander surgery
Microtextured, post-RT
Microtextured, post-RT - group of radiated breast tissue prior to the microtextured-expander surgery
Microtextured, no-RT
Microtextured, no-RT- group of not-radiated breast tissue prior to the microtextured-expander surgery
结局指标
主要结局
Association Between Expander Surface Type and Complications
时间窗: Up to 12 months after reconstruction surgery
Incidence of postoperative complications following implant-based breast reconstruction, including seroma, infection, hematoma, capsular contracture, expander rupture, expander rotation, explantation and perception of breast hardness.
次要结局
未报告次要终点