Elastic Compression Stockings in the Prevention of Varicose Veins Recurrence After Endovenous Thermal Ablation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 319
- 试验地点
- 3
- 主要终点
- Number of patients with clinical recurrence of varicose veins on any lower limb
研究概览
简要总结
Hypothesis. Regular using of Class 1 below-knee graduated compression stockings (RAL GZ 387 standard) compared to the absence of elastic compression will reduce the risk of clinically significant varicose veins recurrence at 12 months after endovenous thermal ablation of the great saphenous vein and elimination of varicose tributaries.
详细描述
The incidence of new varicose veins (VVs) appearance at 3 years after any invasive treatment is about 20%, and the progression rate of chronic venous disease (CVD) at 2 years after the endovenous thermal ablation (ETA) reaches 40%. When comparing open surgery and endovenous laser ablation (EVLA), the frequency of VVs recurrence at 12 months after intervention does not significantly differ and amounts to 10%. A previous study examining the effect of elastic compression on the risk of VVs recurrence after surgery showed a 92% reduction in relative risk. However, it was limited to the low number of followed patients and the absence of the compliance measurement. Thus, there is still no evidence, if long term using of graduated compression stockings (GSV) after modern modalities of VVs treatment (ETA with mini/micro phlebectomy or sclerotherapy) provides any benefits in the reduction of VVs recurrence. Also, there is no information on what regimen for GCS using is effective to reduce the risk of VVs recurrence: continuous use at every day or intermittent using only during specific activities.
Our hypothesis is that regular using of Class 1 below-knee graduated compression stockings (RAL GZ 387 standard) compared to the absence of elastic compression will reduce the risk of clinically significant varicose veins recurrence at 12 months after endovenous thermal ablation of the great saphenous vein and elimination of varicose tributaries.
The aim of the study is to assess the efficacy of regular using of below-knee graduated compression stockings (GCS) of Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) on the risk of varicose veins clinical recurrence after endovenous thermal obliteration of the great saphenous vein and eliminating varicose tributaries in patients without residual varicose veins and / or venous 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)
盲法说明
Blinded outcome assessor has np information on the patients belonging to the Study Group
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
- •Age over 18 years;
- •Varicose veins (VVs) in the system of great saphenous vein (GSV) of one lower limb;
- •Performed endovenous thermal ablation (ETA) of the GSV trunk - endovenous laser ablation (EVLA) or radiofrequency ablation (RFA) - and elimination of varicose tributaries by mini (micro) phlebectomy or sclerotherapy during the 30-45 days before enrollment;
- •The technical success of the performed ETA, the absence of reflux in the GSV trunk and the absence of residual VVs;
- •Lack of signs of chronic venous disease (CVD): clinical class of C0-1 according to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification;
- •Lack of vein-specific symptoms - the intensity of any validated vein-specific symptom is less than 30% according to the numeric rating scale (NRS);
- •Signed informed consent.
排除标准
- •Bilateral VVs;
- •Primary reflux outside the GSV trunk (including combined);
- •History of deep or superficial veins thrombosis;
- •Verified deep vein reflux;
- •Verified non-thrombotic or post-thrombotic venous obstruction;
- •Verified pelvic venous insufficiency;
- •Persistence of superficial reflux after ETA;
- •A tendency for recanalization of previously obliterated veins;
- •Persistence of residual VVs - clinical class of C2 by CEAP;
- •Persistence of signs of CVD - clinical class of C3 and higher by CEAP;
- •Persistence of one or more vein-specific symptom with an intensity of 30% and higher by NRS;
- •The need for long-term use of elastic compression;
- •Contraindications or restrictions for the long-term use of GCS;
- •The need for long-term use of vein-active drugs (more than 1 month);
- •Refusal to participate in the study.
结局指标
主要结局
Number of patients with clinical recurrence of varicose veins on any lower limb
时间窗: 12 months
The primary efficacy outcome is the clinical recurrence of varicose veins at 12 months after the treatment, which means the reappearance of the visible or palpable varicose tributaries on any (treated or non-treated) lower limb.
次要结局
- Number of patients with recanalization of obliterated great saphenous vein(12 months)
- Compliance with the use of GCS(12 months)
- Comfort with GCS(12 months)
- Number of patients with ultrasound recurrence of varicose veins on any lower limb(12 months)
- Number of patients with C0-C1 clinical classes of СVD by CEAP classification(12 months)
- The value of VCSS on the treated limb(12 months)
- The value of CIVIQ-20 score(12 months)
- Number of patients with ultrasound recurrence of varicose veins on treated limb(12 months)
- Number of patients with clinical recurrence of varicose veins on treated limb(12 months)
- Number of patients underwent re-intervention for VVs(12 months)