OBJECTIVES: Quantify endovenous laser ablation (EVLA) with concurrent phlebectomies and ultrasound-guided foam sclerotherapy (UGFS) in cost and effectiveness at 3 weeks and 3 months. DESIGN: Single-centre, prospective, randomised controlled trial. PATIENTS: One hundred patients (100 legs), C(2-6), age 21-78, M:F 42:58, with primary varicose veins received either EVLA under local anaesthetic or UGFS. METHODS: Assessments included duplex, Aberdeen varicose vein questionnaire (AVVQ), venous clinical severity score (VCSS), venous filling index (VFI), visual analogue 7-day pain score and analgesia requirements. Additional treatments with UGFS were performed, if required. Micro-costing, using individually timed treatments, was based on consumables, staff pay and overheads. RESULTS:Changes in AVVQ, VCSS and VFI values (3 months) did not demonstrate any significant difference between groups. At 3 months, the above-knee GSV occlusion rate (without co-existing reflux) was not significantly different between the groups (74% vs 69%; EVLA vs UGFS; P = .596). Of the 9 haemodynamic failures in each group, 7 EVLA patients and 4 UGFS patients had co-existing cross-sectional above-knee GSV occlusion at some point. However, UGFS significantly outperformed EVLA in cost, treatment duration, pain, analgesia requirements and recovery. CONCLUSIONS:UGFS is 3.15 times less expensive than EVLA (£230.24 vs £724.72) with comparable effectiveness but 56% (versus 6%) required additional foam (ISRCTN:03080206).
RCT Entities:
OBJECTIVES: Quantify endovenous laser ablation (EVLA) with concurrent phlebectomies and ultrasound-guided foam sclerotherapy (UGFS) in cost and effectiveness at 3 weeks and 3 months. DESIGN: Single-centre, prospective, randomised controlled trial. PATIENTS: One hundred patients (100 legs), C(2-6), age 21-78, M:F 42:58, with primary varicose veins received either EVLA under local anaesthetic or UGFS. METHODS: Assessments included duplex, Aberdeen varicose vein questionnaire (AVVQ), venous clinical severity score (VCSS), venous filling index (VFI), visual analogue 7-day pain score and analgesia requirements. Additional treatments with UGFS were performed, if required. Micro-costing, using individually timed treatments, was based on consumables, staff pay and overheads. RESULTS: Changes in AVVQ, VCSS and VFI values (3 months) did not demonstrate any significant difference between groups. At 3 months, the above-knee GSV occlusion rate (without co-existing reflux) was not significantly different between the groups (74% vs 69%; EVLA vs UGFS; P = .596). Of the 9 haemodynamic failures in each group, 7 EVLApatients and 4 UGFS patients had co-existing cross-sectional above-knee GSV occlusion at some point. However, UGFS significantly outperformed EVLA in cost, treatment duration, pain, analgesia requirements and recovery. CONCLUSIONS: UGFS is 3.15 times less expensive than EVLA (£230.24 vs £724.72) with comparable effectiveness but 56% (versus 6%) required additional foam (ISRCTN:03080206).