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临床试验/NCT03535012
NCT03535012Unknown不适用

Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options

Yonsei University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Sensory recovery in the reconstructed breast according to reconstructive options

研究概览

简要总结

Over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. Advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed.

With such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. Due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. There has been little research on the mechanism of sensory recovery despite its clinical importance. This study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Female adults over 20 years of age
  • Patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ)
  • written consent to study participation

排除标准

  • presence of neuropathy that may hinder accurate assessment of sensation
  • presence of dermatological condition that may hinder accurate assessment of sensation
  • inability to provide written consent
  • decided by the research team to be unsuitable for this study

结局指标

主要结局

Sensory recovery in the reconstructed breast according to reconstructive options

时间窗: 18 months (±2 months) after immediate breast reconstruction surgery

Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery.

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 (1)

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