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临床试验/NCT06627582
NCT06627582招募中不适用

Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction

Memorial Sloan Kettering Cancer Center14 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
14
主要终点
Number of participants with Persistent Postmastectomy Pain

研究概览

简要总结

The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Age ≥18 years
  • History of mastectomy for breast cancer or genetic predisposition to breast cancer
  • History of breast reconstruction with implants and/or autologous tissue
  • At least 6 months of follow-up after reconstruction
  • Patient treated at MSK

排除标准

  • Exchange or revision surgery within 6 months
  • Active medical reason for pain (e.g., infectious, neoplastic, wound related)
  • Greater than 15 years post-reconstruction

结局指标

主要结局

Number of participants with Persistent Postmastectomy Pain

时间窗: up to 6 months

The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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