Microwave Venous Ablation in Comparison to Radiofrequency Ablation, Laser Ablation and Surgical Ligation in Management of Great Saphenous Vein Incompetence
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 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
- 是
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.
研究组 & 干预措施
Surgical Ligation
Conventional surgical procedures will carried out through a 3-4 cm incision in the groin. The trunk of GSV and the tributaries will be ligated and divided.
干预措施: Varicose vein surgery (Procedure)
Microwave group
The microwave treating wire (Microwave Intracavity Coagulation System; Shanghai Medical Electronics, Shanghai, China) will be inserted into the GSV until it reached the medial aspect of ankle, guided by a light that illuminated the tip of the wire. Then, GSV will be ablated using pulse mode at 20-30 W. The treating wire will be withdrawn at 2-4 mm/s, with the ablation time lasting 2 s (energy delivery to the GSV was estimated at around 80 J/cm); the treatment parameters will be based on a previous report. Tumescence will be used in all patients with 0.9% saline containing 20 mL 2% lidocaine with 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L 0.9% saline.
干预措施: Varicose vein surgery (Procedure)
Laser ablation group
Endovenous Laser Ablation (EVLA) uses a laser Fiber, which is inserted into the abnormal vein via a small skin puncture.using 1470 nm laser and a "radial" fiber for less discomfort. Two weeks later the "branch vessels" have reduced in size
干预措施: Varicose vein surgery (Procedure)
Radiofrequency ablation group
inserts a small catheter into the diseased vein through a small incision, using ultrasound guidance for an accurate and live view. Consistent and uniform heat is delivered to contract the collagen in the vein walls, causing them to collapse and close. After the vein is closed the treated vein is gradually absorbed into surrounding tissue.
干预措施: Varicose vein surgery (Procedure)
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)