Table A5. Clinical Trials Involving RFA Ablation versus Surgical Treatment for Varicose Veins.
Study | Trial Design Objective | Subjects | Co-Interventions | Setting Operator Anaesthesia | Follow-Up |
---|---|---|---|---|---|
Hinchliffe, 2006 (81) | 2-arm within-person RCT Operative and post-operative pain and morbidity in recurrent bilateral VV |
75% (12/16) F Median age 54 years (range 44 - 66) |
Concurrent, phlebectomy | Operating theatre Surgeon General anaesthesia |
6 weeks |
Kianifard , 2006 (89) | Matched case control Occurrence of angiogenesis at 1-year |
39% (20/51) F Mean age 5.4 range 28-83 |
NR | NR Vascular surgeon |
1 week 1 year |
Lurie 2003, 2005 (82;83) | 2-arm RCT Intra-operative and early (4-mo) post-operative complications, recovery, HRQOL Vein ablation, symptoms and HRQOL at 1 and 2-yrs |
73% (52/80) F Median age RFA = 49 ± 4 years, surgery = 47 ± 4 |
Concurrent, adjunctive procedures limited to below knee | Operating theatre 5 sites, surgeons Tumescent anaesthesia with or without regional or general anaesthesia | 4 months 2 years |
Rautio 2002 (85) | 2-arm RCT and costing | 93% (26/28) F Mean age RFA = 33 ± 6.7 |
Concurrent, phlebectomy | Operating theatre Surgeon and for RFA | 8 weeks 3 years |
Perala , 2005 (84) | Post-operative pain, sick leave, HRQOL,, costs | years, surgery = 38 ± 6.8 years | surgeon and an interventional radiologist General anaesthesia |
||
Stotter 2006 (86) | 3-arm RCT | 72% (43/60) F RFA = men 41 years, | Adjunctive procedures not performed | Operating theatre surgeon | 6 weeks 1 year |
Post-operative morbidity, pain, vein closure | women,44 years Invagination stripping = men 54 | ||||
Recanalization and neovascularisation at 1-yr | years, women 51 years Cryostripping = men 42 years, women 41 years | ||||
Subramonia 2008, 2010 (87;88) | 2-arm RCT Vein symptoms, vein ablation and costs |
69% (61/88) F Median age RFA = 47years (range 38-58), surgery = 45 years (range 37 – 53) |
Concurrent, phlebectomy | Operating theatre Surgeons General anaesthesia |
1 week 5 weeks |
RCT refers to randomized controlled trial; GSV, great saphenous vein; SFJ, saphenofemoral junction