Efficacy of MIcronized Purified Flavonoid Fraction-Based Phlebotropic Therapy After Endovenous MechanO-Chemical Ablation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
研究概览
简要总结
This study will be evaluate the clinical efficacy of micronized purified flavonoid fraction (MPFF) phlebotropic therapy for postoperative pain, venospecific symptoms, and quality of life in patients with incompetent great or small saphenous veins (GSV/SSV) following an endovenous mechanochemical ablation procedure (MOCA).
详细描述
The pre-op examination involved taking patient history (including the information about prior venous surgeries), identifying varicose veins (VV's) clinical symptoms/signs, duplex ultrasound (US) evaluation of the lower extremities, clinical-etiological and anatomical-pathophysiological assessment based on the CEAP classification.
The primary transverse and longitudinal US examination (B-mode, color and spectral Doppler) was performed by expert doctors at the Vascular Pathology Non-Invasive Diagnostics Unit before deciding on treatment choices. Reflux in the saphenofemoral/saphenopopliteal junction (SFJ/SPJ) area was determined in supine and upright positions using the Valsalva manoeuvre or manual compression/decompression test, respectively. SFJ/SPJ and great/small saphenous vein (GSV/SSV) segments with retrograde blood flow longer than 0.5 seconds were considered incompetent. Venous reflux section length and incompetent GSV/SSV segments' diameter (in mm) were reflected in medical documentation.
The trial inclusion criteria were as follows: age >18 years old; VV's CEAP clinical class C2-C4; SFJ/SPJ insufficiency and pathological (>0.5 s) reflux in GSV/SSV manifested by one or more "venous" symptoms (pain, itching, nocturnal leg cramps, swelling/pulsing sensation, heaviness, fatigue and overall discomfort), vein diameter at the SFJ/SPJ >4.5 mm and <8 mm in an upright position.
The patients were informed about the MOCA technique, the intervention's potential complications and side effects.
The exclusion criteria included isolated reflux in tributaries, excessive GSV/SSV tortuosity, known allergy to the sclerosant, deep/superficial vein thrombosis, post-thrombotic occlusion, confirmed thrombophilia, postoperative VV recurrence, obliterating peripheral artery diseases (ankle-brachial pressure index <0.8), pregnancy and lactation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Great and small saphenous vein (GSV/SSV) incompetence with reflux at least down to the knee level.
- •Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C
- •Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations).
- •Ability to comprehend and sign an informed consent document.
排除标准
- •Postoperative varicose veins disease recurrence.
- •Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
- •Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.
- •History of pulmonary embolism or stroke.
- •Current anticoagulation therapy (within 7 days of enrollment).
- •Pregnant or lactating women.
研究组 & 干预措施
Group A, MPFF-group
MPFF [Detralex®, Servier, France] 1,000 mg OD for 30 days in the postoperative period.
干预措施: Micronized Purified Flavonoid Fraction (Drug)
结局指标
主要结局
Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
时间窗: 30 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
Number of Participants with venous oedema from absent (score 0) to severe (score 3)
时间窗: 30 days
None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
Number of Participants with pain from absent (score 0) to severe (score 3)
时间窗: 30 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
Number of Participants with inflammation from absent (score 0) to severe (score 3)
时间窗: 30 days
None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
次要结局
- Responders to Treatment, Assessed by Duplex Ultrasound(8 weeks)
研究者
Vladimir Khryshchanovich
Professor
Belarusian State Medical University