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临床试验/NCT03959943
NCT03959943已完成不适用

Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年2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
46
试验地点
1
主要终点
The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments

研究概览

简要总结

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients 18 years or older
  • Unilateral or bilateral LTP flap breast reconstruction
  • Returned for follow-up between February 2016 and April 2019
  • Informed consent

排除标准

  • In case of a total flap loss
  • Flaps that required a take-back
  • Follow-up less than six months postoperatively

结局指标

主要结局

The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments

时间窗: Through study completion up to 27 months postoperatively

The sensory recovery of the breast to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Nine areas of the breast, indicating native skin and flap skin, were tested. Mean monofilament values were calculated for each area and compared between groups.

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

Rene van der Hulst

Head of the Plastic Surgery department

Maastricht University Medical Center

研究点 (1)

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