A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Major Complication Rates
研究概览
简要总结
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.
详细描述
The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.
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
- •Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
- •SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
- •Tissue expander size =<800cc, implant size =<600cc;
- •The blood perfusion of breast skin flap was well;
- •Do not smoking in the last 4 weeks or more
- •Patients with normal expectations and mental health for breast reconstruction;
- •Signed consent to participate
排除标准
- •Poor perfusion of breast mastectomy flap;
- •II stage breast reconstruction patients;
- •History of chest radiotherapy;
- •BMI greater than 35;
- •Patients who have not quit smoking within the last 4 weeks;
研究组 & 干预措施
prepectoral breast reconstruction with Mesh
Immediate prepectoral breast reconstruction with Mesh
干预措施: prepectoral breast reconstruction (Procedure)
prepectoral breast reconstruction with Mesh
Immediate prepectoral breast reconstruction with Mesh
干预措施: Tiloop Mesh implantation (Procedure)
prepectoral breast reconstruction without Mesh
Immediate prepectoral breast reconstruction without Mesh
干预措施: prepectoral breast reconstruction (Procedure)
结局指标
主要结局
Major Complication Rates
时间窗: up to 12 months after surgery
The rate of major complications in the two groups
Patient Breast-Q questionnaire
时间窗: up to 12 months after surgery
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
次要结局
- The rate of surgical revision of reconstructed breasts(up to 12 months after surgery)
- Rates of capsule contracture(up to 24 months after surgery)
- The rate of implant or tissue expander removal(up to 12 months after surgery)
- Minor Complication Rates(up to 12 months after surgery)