Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Target vein occlusion rate as assessed by duplex ultrasound scan
研究概览
简要总结
A prospective, multicenter, non-inferiority, randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins. Patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) elastic bandage for 48h or (B) elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator) , as well as pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to normal work, and compliance.
详细描述
A prospective, multicenter, non-inferiority, randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins. Patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) elastic bandage for 48h or (B) elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator) , as well as pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to normal work, and compliance.
The current study will take place in nine hospitals in six provinces in China. Target Population Patients referred to those with primary lower extremity saphenous varicose veins diagnosed in 9 target hospitals from April 2023 to August 2023, and all participants included in the trial signed an informed consent form.
Intervention
Group A: elastic bandage for 48h Group B: elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week Follow-up
At baseline, patients will be asked to fill a validated visual analogue scale (VAS) , quality of life questionnaires (AVVQ), and clinical severity of varicose veins (VCSS) . They will also be asked to attend a follow-up in 1 week and at 3 months.
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
- 否
入选标准
- •Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years
- •Patients with CEAP classification of C2-C4 stage
- •2mm≤diameter of the main trunk of the saphenous vein in the thigh segment ≤15mm
- •Agree to participate in this study and voluntarily sign the informed consent form
排除标准
- •Patients who have difficulty tolerating surgery
- •The main trunk of the saphenous vein is extremely twisted or tightly attached to the skin
- •Previous history of ipsilateral varicose vein surgery in the lower extremity
- •Combined deep vein thrombosis in the affected lower extremity or previous deep vein thrombosis in the affected lower extremity
- •Uncorrectable coagulation dysfunction or significant blood abnormalities with significant bleeding tendency (platelets ≤ 30*10^9/L)
- •Acute thrombosis in the saphenous vein
- •Combination of the affected lower extremity lower extremity atherosclerotic occlusive disease who
- •Ankle-brachial index ABI < 0.6 and/or absolute ankle pressure < 60 mmHg
- •Patients who cannot wear elastic stockings or are allergic to elastic bandages or elastic stockings
- •Patients during pregnancy or lactation
- •Previous history of pulmonary embolism
- •Participating in clinical trials of other drugs or devices
- •Other patients deemed unsuitable for this study by the investigator
结局指标
主要结局
Target vein occlusion rate as assessed by duplex ultrasound scan
时间窗: 3 months post-op
The primary outcome of the study is target vein occlusion rate at 3 months assessed with duplex ultrasound scan. Recanalisation will be defined by a segment of vein≥5cm. Target vein occlusion rate = Number of target venous closure cases in the group/total number of cases in the group
次要结局
- Venous clinical severity score as assessed by VCSS(Baseline, 1 week post-op, 3 months post-op)
- Quality of life score as assessed by AVVQ(Baseline, 1 week post-op, 3 months post-op)
- Pain score as assessed by VAS(Baseline, 1 week post-op, 3 months post-op)
- Compliance(1 week post-op, 3 months post-op)
- Postoperative complications(1 week post-op, 3 months post-op)
- Time to return to normal work(1 week post-op, 3 months post-op)