Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Oberösterreich
-
Linz、Oberösterreich、奥地利、4020
- 招聘中
- 2.Chirurgische Abteilung AKh Linz GesmbH
-
接触：
- Katharina Bröderbauer
- 电话号码：0043 732 7806 2133
- 邮箱：chirurgie2@akh.linz.at
-
首席研究员：
- Markus MS Schreiner
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1470nm Laser
Patient with varicose vein treated with 1470nm Laser (Biolitec)
|
Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
|
|
有源比较器：VNUS Closure Fast
Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
|
Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain
大体时间：day 0
|
Pain (visual analogue scale) on the day of treatment
|
day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Obliteration of the treated vein (GSV or SSV)
大体时间：day 10, month 3, month 12
|
An ultrasound investigation of he treated vein is done to find out if the treated vein is fully obliterated or not.
If it is not fully obliterated we want to find out if there is any pathological reflux in the vein.
|
day 10, month 3, month 12
|
|
Patient´s satisfaction after the intervention
大体时间：day 10, month 3, month 12
|
The patient is asked about his/her satisfaction after intervention.
This is measured on a numeric scale from 1 to 5 (like schoolmarks in austria or germany).
1=very good, 2=good, 3=average, 4=not so good, 5=bad)
|
day 10, month 3, month 12
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
paresthesia of the lower leg after intervention
大体时间：day 10, month 3, month 12
|
patients are asked if there is any paresthesia of the lower leg - "yes" or "no"
|
day 10, month 3, month 12
|
合作者和调查者
调查人员
- 首席研究员：Markus Schreiner、2.Chirurgische Abteilung AKh Linz GesmbH
- 学习椅：Andreas Shamiyeh、2. Chirurgische Abteilung AKh Linz GesmbH
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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