NCT02339779进行中（未招募）不适用
the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 8
- 主要终点
- Breast-related Quality of life (BREAST_Q)
研究概览
简要总结
This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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' choice to undergo a breast reconstruction
- •Wanting to participate in this study
- •Patient is able to wear the BRAVA 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
- •Claustrophobia for an MRI-scan
结局指标
主要结局
Breast-related Quality of life (BREAST_Q)
时间窗: 1 year
Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively
次要结局
- Complications(1 year)
- Oncological safety(5 years)
- Aesthetic result(1 year)
- Donor site satisfaction(2 years)
- Cost-effectiveness(1 year)
- Sensibility(1 year)
研究者
研究点 (8)
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