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临床试验/NCT06685926
NCT06685926已完成不适用

Groin-Only Lymphaticovenous Anastomosis for Lower Extremity Lymphoedema: a Retrospective Cohort Propensity-Score Matched Analysis of a Novel Supermicrosurgical Concept

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
189
试验地点
1
主要终点
Volume change after LVA

研究概览

简要总结

This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity lymphoedema.

详细描述

Lymphaticovenous anastomosis (LVA), a surgical technique that connects lymphatic vessels (LVs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid.

Conventional LVA treatment for lower extremity lymphoedema (LEL) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of LVs and recipient veins in the distal regions.

Based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal LVA around the groin region for LEL could be theoretically advantagous, but its clinical efficacy compared to conventional distal LVA remains underexplored.

研究设计

研究类型
Observational

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 diagnosed with lymphatic-related diseases to the lower extremity
  • Patients who is undergoing LVA for unilateral lower-limb lymphedema.

排除标准

  • Primary lymphedema
  • Bilateral lower limb lymphedema
  • History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
  • Patients who recieved both LVA to the groin site and non-groin site.

结局指标

主要结局

Volume change after LVA

时间窗: 6 and 12 months

The primary endpoint is limb volume change at 6 and 12 months after intervention, measured using magnetic resonance volumetry.

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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