NCT07419971Enrolling By Invitation不适用
Influencing Factors and Mechanisms of Capsular Contracture After Prosthesis Reconstruction in Patients With Breast Cancer
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Aesthetic Outcome
研究概览
简要总结
The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adults aged 18 years or older; Undergoing mastectomy for breast cancer or prophylactic reasons; Receiving immediate implant-based reconstruction (either implant-only or combined with an autologous flap)
排除标准
- •Delayed reconstruction; Purely autologous reconstruction (without an implant); Incomplete postoperative follow-up data precluding effective aesthetic assessment
研究组 & 干预措施
Mesh
implant- based breast reconstruction with synthetic mesh
干预措施: synthetic mesh (Procedure)
Without Mesh
implant- based breast reconstruction without synthetic mesh
结局指标
主要结局
Aesthetic Outcome
时间窗: From enrollment to the end of follow up at 6 months
Half a year post-IBBR, patients underwent a structured interview and physical examination by two independent senior breast surgeon, blinded to the surgical details, during outpatient visits using the Ueda Aesthetic Scale, "Excellent'" (9-10 points), ''Good'' (7-8points), ''Fair'' (5-6 points) and ''Poor'' (0-4 points).
次要结局
未报告次要终点
研究者
Qing LYU
Chief Physician
West China Hospital
研究点 (1)
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