Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Compression Stockings Treatment After Endovenous Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Tension blisters after radiofrequency ablation
研究概览
简要总结
Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.
详细描述
Postoperative compression of varicose veins can achieve compression hemostasis, early getting out of bed, reducing edema, preventing phlebitis, ensuring closure effect, reducing soreness and pain, and preventing thrombosis. Compression therapy is a continuation of minimally invasive treatment of varicose veins, and postoperative compression therapy is continued for at least 1 month, and grade II compression therapy may be considered.The application of postoperative compression to the treated limb after radiofrequency ablation of the great saphenous vein has been a topic of controversy. The basic principle of using postoperative compression is to reduce the risk of bleeding, hematoma formation, pain, swelling, and thrombus formation. However, many patients find wearing gradient pressure elastic stockings cumbersome and uncomfortable, as the silicone grips around the stockings can cause skin itching and discomfort. Moreover, there is a lack of strong evidence supporting this treatment. The purpose of this study was to investigate the effectiveness of continuous 48-hour use of gradient pressure elastic stockings for compression of the affected limb after endovenous radiofrequency ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years and <80 years, and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up.
- •C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV, or AASV incompetence, with reflux >0.5 seconds on color duplex, eligible for patients undergoing radiofrequency ablation.
- •Color replica ultrasound or venography of the lower extremity veins shows saphenous varicose veins without evidence of deep venous stenosis, filling defects, or ultrasound abnormalities.
- •No contraindications to the wearing of compression stockings (e.g., arterial insufficiency, skin allergies)
排除标准
- •Severe deep vein valve insufficiency or acute deep vein thrombosis of the lower extremities
- •Previous history of high ligation and dissection of the saphenous vein, recurrence of collateral branches of the deep vein
- •Superficial vein thrombosis is present at the treatment site, with local redness, swelling, warmth, pain, and significant signs of inflammation
结局指标
主要结局
Tension blisters after radiofrequency ablation
时间窗: 2 days post-procedure
Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower extremity skin tension blister events was obtained, with 0 indicating negative and 1 indicating positive
Pain after radiofrequency ablation
时间窗: 2 days post-procedure
Pain is assessed using a visual analogue score (1-10), with higher scores representing more pronounced pain。
Bleeding after radiofrequency ablation
时间窗: 2 days post-procedure
Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower limb bleeding events was obtained, with 0 representing no bleeding events and 1 representing bleeding events
次要结局
- Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)(2 days, 1 month, 3 months, 1 year after surgery)
- The rate of occlusion of treated vein post-procedure(2 days, 1 month, 3 months, 1 year after surgery)
- Clinical Change using Venous Clinical Severity Score (VCSS)(2 days, 1 month, 3 months, 1 year after surgery)
研究者
Chunshui He
chief physician
Chengdu University of Traditional Chinese Medicine