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临床试验/NCT04479956
NCT04479956Unknown不适用

Microwave Venous Ablation in Comparison to Radiofrequency Ablation, Laser Ablation and Surgical Ligation in Management of Great Saphenous Vein Incompetence

Mansoura University4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年6月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
4
主要终点
Great Saphenous vein patency

研究概览

简要总结

The authors will aim to compare microwave therapy with other lines of management radio-frequency ablation, Laser ablation and surgical ligation; regarding time to recurrence rate, ulcer-free time, and health-related quality of life. In a randomized controlled study,The study will be conducted at the department of vascular surgery in Mansoura university hospitals

详细描述

INTRODUCTION:

Chronic venous disease (CVD) is one of the most common pathologies in the general population of adults in both industrialized and developing countries.1 the most severe form of CVD is venous ulceration with an overall prevalence of about 1 % in the adult population, which increases with age and is more common in women and obese patients. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems. Varicose veins (VVS) is a common disease in adults, and VVS without skin changes are present in about 20% of the population, while active ulcers are found in 0.5%. The traditional surgical treatment of VVS is high ligation of the great saphenous vein (GSV), axial stripping and phlebotomy, but the postoperative clinical recurrence is as high as 60%.

Recently, minimally invasive techniques, such as endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), have become widely used for the treatment of VVS. Several reports have shown Several reports have shown that endovenous techniques are as effective as traditional procedures.

Endovenous Microwave Ablation (EMA) for the treatment of VVS differs from the other endovenous methods, and no specific dose regime has been established for this system. Thus, it is unclear if EMA is more or less effective than conventional surgery, or whether it has any additional benefits. In this study, we compared the clinical outcome of high ligation and stripping (HLS) with EMA. Postoperative quality of life (QoL) analysis was assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) and Venous Clinical Severity Score (VCSS).

Aim of the work: Aimed to compare microwave therapy with other lines of management radiofrequency ablation, Laser ablation and surgical ligation; regarding time to recurrence rate, ulcer-free time, and health-related quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Computer Based

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary symptomatic VVS (CEAP, C3 , C6),
  • Sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee

排除标准

  • A history of venous surgery, suspected or proven deep venous thrombosis,
  • Reflux of deep veins to distal limb
  • Duplication of GSV
  • Patients' refusal to participate in the trial.

结局指标

主要结局

Great Saphenous vein patency

时间窗: 6 months

Lack of flow or closed great saphenous vein

Operation Time

时间窗: intraoperative

The time of the whole procedure

次要结局

  • Recurrence varicose vein(12 Months)
  • Adverse effect of the procedure(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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