Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Vein closure success rate.
研究概览
简要总结
In this proposal, the investigators seek to determine whether a reduced compression after endovenous ablation procedure in treating superficial venous insufficiency affects the outcomes. This study involves only the use of the compression stocking post endovenous ablation procedure and everything else is standard according to current guidelines.
The investigators general strategy will be to determine the role of a minimal post-operative compression and the status of patient satisfaction including (1) Success closure rate of the treated vein. (2) Less pain; (3) Easier accepted by the patients.
详细描述
All adults with varicose vein who are here in the investigators clinic to seek for endovenous ablation treatments will be invited to participate in this study. The participation in this research is entirely voluntary.
A. Each patient is given a code number instead of ID(identification) in the chart. Eligible patients according to their vein size are divided into following groups using a computer-generated randomization list:
- Vein diameter between 5.5 and 6.7 mm, Post-op compression 1 day;
- Vein diameter between 5.5 and 6.7 mm, Post-op compression 7 days;
- Vein diameter between 6.8 and 8.5 mm, Post-op compression 3 days;
- Vein diameter between 6.8 and 8.5 mm, Post-op compression 7 days.
B. Researchers: Data collectors and ultrasound technicians are blinded to the type of intervention, using code instead of patient's ID. The operating surgeon will not be the one who collects data. Performing physicians master these endovenous procedure techniques equally, have performed a minimum of 20 procedures independently.
C. Device: Graduated medical compression hosiery, 15-20mmHg. BrightLife Direct, Washington, DC. Endovenous ablation device: 1. Radiofrequency Ablation- FDA approval 1999, VNUS RFG2, San Jose, CA; 2. Endovenous Laser ablation- FDA approval Jan 2002, TVS 1470 by Total Vein System. Wavelength 1470nm, Nano Laser System device, Houston, TX. These two procedures are standard care under current guideline.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Aged 18 and older
- •Diagnosis - symptoms (pain, burning, itching, cramping, heaviness and tiredness of leg, restless leg, swelling leg, etc.) and clinical signs (dilated veins, lipodermatosclerosis, color and texture changes of the skin, edema of leg, wound) correlates with vein diameter >5.5mm and reflex (>0.5 sec) in the upright position identified with duplex ultrasound
- •Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic) 3 or higher
- •Fail to a minimum of three months of nonoperative management (leg elevation, avoidance of prolonged standing, weight reduction, daily exercise for 30 min, prescription strength gradient compression garments, NSAIDs<nonsteroidal antiinflammatory drug>)
- •Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small saphenous vein (SSV).
排除标准
- •Documented allergy or intolerance to compression hosiery
- •Treated vein greater than 8.5 in diameters.
- •Previous history of DVT(deep venous thrombosis); Known prothrombotic state.
- •Arterial insufficiency as determined by ABI(ankle-brachial index)<0.
- •Obesity (BMI >35, class II).
结局指标
主要结局
Vein closure success rate.
时间窗: up to 12 months.
Vein closure success rate determined by clinical evidence of symptom improvement and post-procedure duplex ultrasound @ 7 days, 1, 3, 6, 12 months.
次要结局
未报告次要终点