Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Pain score and use of painkillers
研究概览
简要总结
A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.
详细描述
* Study type: Interventional. Randomized comparative clinical trial..
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Outcome measures:
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Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
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Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
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Outcome measures time frame:
Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.
* Focus of the study: Varicose great saphenous veins (GSV)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec, and diameter of vein > 0.5 cm
- •Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
- •No prior treatment of the insufficient GSV
- •Informed consent
排除标准
- •Acute deep or superficial vein thrombosis
- •Agenesis of deep vein system
- •Vascular malformation or syndrome
- •Post-thrombotic syndrome, occlusive type
- •Pregnancy
- •Immobility
- •Allergy to lidocaine
- •Arterial insufficiency
- •Diameter of GSV ≤ 0.5 mm at puncture site
结局指标
主要结局
Pain score and use of painkillers
时间窗: 1 week post treatment
A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.
Health related quality of life
时间窗: 0 and 12 weeks post treatment
Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.
Treatment satisfaction
时间窗: 1 week post treatment
A NRS of satisfaction is filled in by the patient.
次要结局
- Number of participants with adverse events(The adverse events will be assessed at 1 and 12 weeks post treatment.)
- Occlusion of the treated GSV (effectiveness)(The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.)
研究者
Wendy Malskat
MD
Erasmus Medical Center