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临床试验/NCT04552938
NCT04552938已完成不适用

The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
the correlation between post-LVA volume reduction

研究概览

简要总结

The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).

详细描述

In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.

研究设计

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

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with lower limb lymphedema confirmed with lymphoscintigraphy
  • unilateral lower limb lymphedema
  • lymphedema duration > 2 years
  • no active infection
  • no prophylactic antibiotic use for at least one month before LVA
  • no tumor recurrence or metastasis
  • no consumption of antioxidants, such as vitamin E or ascorbic acid

排除标准

  • Patients with upper limb and bilateral lower limb lymphedema

结局指标

主要结局

the correlation between post-LVA volume reduction

时间窗: 6 months after surgery

The primary outcome was determined whether post-LVA volume reduction \< 40%

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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