跳至主要内容
临床试验/NCT05822115
NCT05822115招募中不适用

Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

Groupe Hospitalier Nord-Essonne2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年4月24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
5
试验地点
2
主要终点
Photography of the scar

研究概览

简要总结

The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.

This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.

详细描述

Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects.

On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy.

Ultimately, the results of this study may serve as a basis for further research by proposing:

  • Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar.
  • A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Photography of the scar

时间窗: at 3 months

centimeter

次要结局

  • Scar assessment(at 3 weeks)
  • Photography of Areola(at 3 weeks, 3 months and 1 year)
  • Resection weight(at 0 day)
  • Scar lenght(at 3 weeks, 3 months and 1 year)
  • Cancer(at day 0)
  • Macroeconomic impact(at 1 year)
  • Pain scale(at 3 weeks, 3 months and 1 year)
  • Satisfaction scale(at 3 weeks, 3 months and 1 year)
  • Scar thickness(at 3 weeks, 3 months and 1 year)
  • Blood loss(at 1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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