NCT06374628招募中不适用
Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction: Indications, Surgical Technique and Clinical Outcomes With Histological and Ultrasound Follow-up
Rossella Elia, MD PhD1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
- •risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM
排除标准
- •partial or total submuscular tissue expander placement,
- •tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
- •previous breast surgery
结局指标
主要结局
Patient satisfaction
时间窗: 24 months of follow-up
Patients satisfaction will be evaluated through BREAST-Q questionnaire. the results from the questionnaire will be converted into a 0-100 scale with higher values meaning a better outcome
次要结局
- Pain Evaluation(24 months of follow-up)
研究者
Rossella Elia, MD PhD
Full time researcher, Unit of Plastic and Reconstructive Surgery, Policlinico of Bari
University of Bari
研究点 (1)
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