Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .
详细描述
The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.
In this study there are no additional risk factors for the included study patients except the risk of surgery.
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
- •varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
- •maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm
排除标准
- •surgical treatment of the saphenous vein in the past
- •sclerotherapy of the saphenous vein in the past
- •phlebitis or thrombosis of the saphenous vein
- •surgical treatment of an venous ulcer in the past
- •postthrombotic syndrome
- •erysipelas of the leg in the past
- •chronic treatment with pain-killers or chronic alcoholism
- •pregnancy
- •drug allergy against painkillers that are used in this study
- •spinal anesthesia not possible
- •compression bandage not possible
- •patients with polyneuropathy
- •patients with chronic pain
- •persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
- •participation on an other clinical trial that can interfere with this clinical trial
- •missing written informed consent
结局指标
主要结局
Pain
时间窗: day 0
Pain (visual analogue scale) on the day of treatment
次要结局
- Obliteration of the treated vein (GSV or SSV)(day 10, month 3, month 12)
- Patient´s satisfaction after the intervention(day 10, month 3, month 12)
研究者
Dr. Markus Schreiner
Oberarzt
Ludwig Boltzmann Institute for Operative Laparoscopy