Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.

AIM: This study is a prospective randomised controlled trial comparing sapheno-femoral ligation, great saphenous stripping and multiple avulsions with sapheno-femoral ligation and ultrasound guided foam sclerotherapy to the saphenous vein. Primary end points were patient recovery period and quality of life and secondary end points frequency of complications on the two arms of the trial and the cost of the treatment. MATERIAL AND
METHOD: Sixty patients with primary varicose veins due to GSV incompetence and suitable for day case surgery were randomly allocated to undergo ultrasound-guided sclerotherapy with sapheno-femoral ligation under local anaesthesia (n=30) or sapheno-femoral ligation, stripping and multiple avulsions under general anaesthesia (n=30). The study protocol included history, physical examination, assignment of CEAP class and assessment venous clinical severity score (VCSS), completion of the aberdeen vein questionnaire (AVQ) and colour duplex ultrasound.
RESULTS: All treatments were completed as intended. Median time to return to normal activities was significantly reduced in the foam sclerotherapy group (2 days) compared to the surgical group (8 days) (p<0.001, Mann-Whitney). AVQ score was also significantly reduced at 3 months by 46% in the sclerotherapy group, and by 40% in the conventional surgery group (p<0.001, Wilcoxon). The time taken to complete treatment was shorter in the foam sclerotherapy plus SFJ ligation group: 45 vs. 85 min (p<0.001, Mann-Whitney). The overall cost of the procedure in the sclerotherapy group ( 672.97 pounds) was significantly less compared to conventional surgery ( 1120.64 pounds). At 3 weeks, there was no statistical difference in the complication rate between the two groups. At 3 months, median CEAP class dropped from four pre-operatively to one following treatment in both groups and the median VCSS score dropped from five to one in group one and from seven to three in group two (p<0.001, Wilcoxon test). In group one four patients (13%) had a recanalised vein which needed further sessions of foam sclerotherapy, resulting in a short-term closure rate of 87%.
CONCLUSION: Ultrasound guided sclerotherapy combined with sapheno-femoral ligation was less expensive, involved a shorter treatment time and resulted in more rapid recovery compared to sapheno-femoral ligation, saphenous stripping and phlebectomies.

RCT Entities:   Population Interventions Outcomes