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临床试验/NCT02017106
NCT02017106已完成不适用

Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Hull University Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Disease specific QoL (AVVQ)

研究概览

简要总结

Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. This trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.

详细描述

Endovenous laser therapy (EVLT) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. Randomized trials and meta-analyses have confirmed the efficacy of EVLT in comparison with surgery and other endovenous techniques. There is also evidence that it may be associated with early quality of life (QoL) benefits compared with surgery. The general efficacy of EVLT has therefore been demonstrated and current research focuses on refinement of the procedure. A fundamental question concerns the management of residual varicosities following truncal laser ablation. One approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. This approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). Another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (EVLTAP). The aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • primary, symptomatic, unilateral varicose great saphenous veins (GSV), with isolated saphenofemoral junction (SFJ) incompetence and GSV reflux on venous duplex imaging,
  • perigenicular vein diameter exceeding 4 mm,
  • acceptance by the patient of a local anaesthetic procedure.

排除标准

  • saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging
  • did not give consent to trial participation.

研究组 & 干预措施

Concomitant phlebectomies

Experimental

Removal of varicose tributaries during Endovenous laser ablation

干预措施: Endovenous Laser ablation and concomitant phlebectomies (Procedure)

Concomitant phlebectomies

Experimental

Removal of varicose tributaries during Endovenous laser ablation

干预措施: Endovenous Laser ablation and sequential phlebectomies (Procedure)

Sequential Phlebectomies

Active Comparator

Endovenous laser ablation only

干预措施: Endovenous Laser ablation and concomitant phlebectomies (Procedure)

Sequential Phlebectomies

Active Comparator

Endovenous laser ablation only

干预措施: Endovenous Laser ablation and sequential phlebectomies (Procedure)

结局指标

主要结局

Disease specific QoL (AVVQ)

时间窗: 5 years

次要结局

  • Number of secondary procedures(5 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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