Clinical Research Directory

Endovenous Laser Ablation With 1940 nm Versus 1470 nm

Sponsor: Kafrelsheikh University

Summary

1. 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. 2. 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}}. 3. 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. 4. 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. 5. 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. 6. 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). 7. 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). 8. 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}.

Official title: Clinical Outcomes of Endovenous Laser Ablation With 1940 nm Versus 1470 nm for the Treatment of Varicose Veins [ Randomized Controlled Trial]

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