跳至主要内容
临床试验/NCT05917834
NCT05917834已完成不适用

Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Loss of NAC sensory by pinprick test

研究概览

简要总结

This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females who are older than 18
  • Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital

排除标准

  • Loss or excision of NAC due to post-surgical necrosis
  • Diagnosis of other conditions that may interfere with cutaneous sensation

结局指标

主要结局

Loss of NAC sensory by pinprick test

时间窗: 2-4 years after surgery

Difference in NAC sensory loss between the patients with two different incisions.

次要结局

未报告次要终点

研究者

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

Joon Jeong

Professor

Gangnam Severance Hospital

研究点 (1)

Loading locations...

相似试验