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临床试验/NCT05508581
NCT05508581已完成不适用

Microwaves Ablation of Varicose Veins

Assiut University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月1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
20
试验地点
1
主要终点
1.Number of Participants with Lack of flow or closed great saphenous vein

研究概览

简要总结

Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives.

详细描述

Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives. Endo venous thermal ablation, such as radiofrequency ablation and endo venous laser ablation (EVLA), has become the recommended first-line treatment for VVs worldwide. These endo venous procedures provide a quicker recovery time and improved QoL and produce fewer complications than traditional surgery .Endo venous microwaves ablation is a minimally invasive procedure in treatment of V.V, investigators confirmed that endo venous microwave ablation (EMA) was an effective new technique for the treatment of VVs. On previous trials confirmed that the endo venous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endo venous laser ablation procedure. The aim of the study was to determine whether endo venous microwave ablation of varicose vein was associated with better effectiveness and less complications and evaluate the outcome of patients who underwent endo venous microwave ablation (EMA).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years, either sex, elective admission
  • primary symptomatic VVS (CEAP,C3-C6)
  • Recurrent Varicose Veins after surgery
  • Greater saphenous vein diameter up to 3 cm
  • Greater saphenous vein with variable depth even with depth less than 6mm
  • Greater saphenous vein with tortuosity
  • Diabetic patient with risk of wound infection after surgery
  • Patient with hostile groin
  • Availability of patients for all follow-up visits

排除标准

  • secondary Varicose Veins
  • Acute thrombosis near the Saphenous-femoral junction
  • Recanalized Greater saphenous vein

结局指标

主要结局

1.Number of Participants with Lack of flow or closed great saphenous vein

时间窗: 6 months

Complete ablation of varicose veins done or if any residual remind

2.Operation time

时间窗: Intraoperative

The time of the whole procedure

次要结局

  • 1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation(12 month)
  • 2. Number of Participants with adverse effect of the procedure(12 months)

研究者

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

joseph samy youssef saleeb

Principal investigator

Assiut University

研究点 (1)

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