NCT07445425尚未招募不适用
Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 206
- 试验地点
- 21
- 主要终点
- The re-intervention rate
研究概览
简要总结
The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are:
Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies?
Participants will:
Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination.
Record their symptoms
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 (Outcomes Assessor)
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
- 是
入选标准
- •aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.
排除标准
- •Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) <0.6 and/or absolute ankle pressure <60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter>3.5mm; any other patients investigator considers improper to participate in this study.
研究组 & 干预措施
A
Experimental
干预措施: Staged surgery group (Procedure)
B
Placebo Comparator
干预措施: Concomitant surgery group (Procedure)
结局指标
主要结局
The re-intervention rate
时间窗: 1 week, 3 months and 6 months after surgery
次要结局
- Treatment cost(6 months after surgery)
- Success rate of varicose vein closure(1 week, 3 months and 6 months after surgery)
- Operation time(During the operation)
- Number of incisions(During the operation)
- Tumescent anesthesia solution dosage(During the operation)
- The amount of intraoperative bleeding(During the operation)
- AVVQ score(Before surgery, 1 week, 3 months and 6 months after surgery)
- VAS score(Before surgery, 1 week, 3 months and 6 months after surgery)
- VCSS score(Before surgery, 1 week, 3 months and 6 months after surgery)
- Postoperative complications(1 week, 3 months and 6 months after surgery)
- Time to return to regular work(1 week after surgery)
- Patient satisfaction(During the operation and 6 months after surgery)
研究者
研究点 (21)
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