NCT04245930Unknown不适用
A Randomized and Controlled Study of Efficacy and Safety of Bovine Pericardial Patch and TiLOOP® Bra Mesh in Patients With Immediate Implant Breast Reconstruction.
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Complication Rates
研究概览
简要总结
This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with I~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
- •Do not smoking in the last 4 weeks or more
- •Mental health patients
- •Signed consent to participate
排除标准
- •Locally advanced stage patients or patients with distal metastasis
- •Patients received thoracic wall radiotherapy or will receive radiotherapy
- •Smoking in the last 4 weeks
- •Anticipated implant volume more than 600cc
- •Patients of pregnancy or lactation
- •Patients received neoadjuvant therapy
结局指标
主要结局
Complication Rates
时间窗: up to 12 months after surgery
The rate of complications in the two groups
次要结局
- Cosmetic outcome of reconstructed breast(Immediately, up to 3 months, 6 months and 12 months after surgery)
- Health economics-inpatient cost(up to 12 months after surgery, including the cost of surgical revision)
- Patient satisfaction-Breast-Q questionnaire(up to 12 months after surgery)
- The rate of surgical revision of reconstructed breasts(up to 12 months after surgery)
研究者
研究点 (1)
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