NCT07603570进行中（未招募）3 期
Clinical Outcomes of Endovenous Laser Ablation With 1940 nm Versus 1470 nm for the Treatment of Varicose Veins [ Randomized Controlled Trial]
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 1
研究概览
简要总结
- Study Design: A single-blind, prospective, randomized controlled trial (RCT) conducted at Kafrelsheikh University Hospital to compare the efficacy and safety of 1940 nm vs. 1470 nm diode lasers for EVLA.
- Participants: The trial will enroll 220 adult patients (110 per group) presenting with symptomatic varicose veins (CEAP C2-C6) and duplex-proven saphenous reflux with a vein diameter \bm{< 12\text{ mm}}.
- Randomization & Blinding: Patients are randomized in a 1:1 ratio via computer-generated sequences in sealed envelopes; patients and outcome assessors are strictly blinded, while the operating surgeon is unblinded.
- Anesthesia: Procedures are performed under ultrasound-guided Local Tumescent Anesthesia (0.1% lidocaine with sodium bicarbonate in saline) to provide analgesia, a thermal sink, and venous compression.
- Surgical Technique: A 600-µm radial fiber is introduced through a 6F sheath and positioned 2 cm distal to the SFJ/SPJ, followed by ablation in the Trendelenburg position at a pullback speed of 1 mm/s.
- Laser Metrics: Group I (1940 nm) will utilize lower power settings (4-6 W; target LEED 30-50 J/cm), while Group II (1470 nm) will follow standard practice guidelines (10-12 W; target LEED 60-80 J/cm).
- Follow-up & Outcomes: Longitudinal surveillance will occur at Day 1, Day 7, 1 month, and 6 months, with the primary outcome defined as anatomical success (complete vein occlusion via duplex ultrasound at 6 months).
- Statistical Analysis: Secondary metrics-including pain (VAS), clinical improvement (VCSS), and complications (EHIT, paresthesia)-will be analyzed via IBM SPSS, establishing a significance threshold of \bm{p < 0.05}.
详细描述
Methods Study Design and Setting This will be a prospective, randomized, controlled clinical trial designed to compare Endovenous Laser Ablation (EVLA) with 1940 nm versus 1470 nm diode lasers for the treatment of varicose veins.
The study will be conducted at the Vascular and Endovascular Surgery Department of Kafrelsheikh university hospital with recruitment from the outpatient vascular clinics. The trial will adhere to the principles of the Declaration of Helsinki and follow CONSORT guidelines for randomized trials. Ethical approval will be obtained from the Institutional Research Ethics Committee prior to study initiation.
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Participants Inclusion Criteria
- Adult patients (≥18 years) diagnosed with symptomatic varicose veins.
- Clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification C2-C6.
- Duplex ultrasound evidence of saphenous vein incompetence (reflux ≥0.5 seconds in standing position).
- Great saphenous vein (GSV), small saphenous vein (SSV), or accessory saphenous vein diameter suitable for endovenous treatment (<12 mm).
- Patients able to provide informed consent. Exclusion Criteria
- Prior surgical or endovenous treatment of the affected vein.
- Vein diameter >12 mm at the target segment.
- Presence of deep venous thrombosis, superficial thrombophlebitis, or congenital venous anomalies.
- Known allergy to lidocaine or components of the tumescent anesthesia solution.
- Severe comorbidities or debilitating systemic disease contraindicating the procedure.
- Pregnant or lactating women.
- Patients unable or unwilling to provide informed consent or comply with follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients (≥18 years) diagnosed with symptomatic varicose veins.
- •Clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification C2-C
- •Duplex ultrasound evidence of saphenous vein incompetence (reflux ≥0.5 seconds in standing position).
- •Great saphenous vein (GSV), small saphenous vein (SSV), or accessory saphenous vein diameter suitable for endovenous treatment (<12 mm).
- •Patients able to provide informed consent.
排除标准
- 未提供
研究者
Taha Elsayed Abdelwahab Mohamed
resident doctor
Kafrelsheikh University
研究点 (1)
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