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临床试验/NCT01738048
NCT01738048已完成不适用

Persistent Pain After Reconstruction Following Mastectomy

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 1,352 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,352
试验地点
1
主要终点
The risk of developing persistent if reconstructed

研究概览

简要总结

A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.

详细描述

The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with unilateral primary breast cancer aged 18-70 years

排除标准

  • recurrent cancer
  • other malignancy
  • emigration
  • non-standardized treatment

结局指标

主要结局

The risk of developing persistent if reconstructed

时间窗: Cross-sectional, 2-3 years after surgery for breast cancer

The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.

次要结局

  • Prevalence of persistent pain after reconstruction after mastectomy(Cross-sectional, 2-3 years after surgery for breast cancer)
  • Prevalence of sensory disturbances after reconstruction after mastectomy(Cross-sectional, 2-3 years after surgery for breast cancer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Geving Andersen

Physician, research fellow

Rigshospitalet, Denmark

研究点 (1)

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