NCT04261829招募中不适用
Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 8
- 主要终点
- Breast-related Quality of life
研究概览
简要总结
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.
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 gender
- •Age of 18 years and older
- •History or in candidate for a mastectomy procedure in the near future
- •Patients undergoing preventive mastectomy
- •Patients' choice to undergo a breast reconstruction
- •Wanting to participate in this study
- •Patient is able to wear the external expansion device
排除标准
- •Active smoker or a history of smoking 4 weeks prior to surgery
- •Current substance abuse
- •History of lidocaine allergy
- •History of silicone allergy
- •4 weeks or less after chemotherapy
- •History of radiation therapy in the breast region
- •Oncological treatment includes radiotherapy after mastectomy
- •Kidney disease
- •Steroid dependent asthma (daily or weekly) or other diseases
- •Immune-suppressed or compromised disease
- •Uncontrolled diabetes
- •Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
- •Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
- •The treating plastic surgeon has strong doubts on the patient's treatment compliance
结局指标
主要结局
Breast-related Quality of life
时间窗: 2 years
Measured by the BREAST-Q questionnaire (quality of life subdivision)
次要结局
- Oncological safety(5 years)
- Cost-effectiveness(2 years)
- Aesthetic result(2 years)
- Complications(2 years)
研究者
研究点 (8)
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