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. 2011 Feb 1;11(1):1–93.

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