Aim: This study is a prospective randomized controlled trial comparing ultrasound-guided foam sclerotherapy of the great saphenous vein (GSV) combined with sapheno-femoral junction (SFJ) ligation to standard stripping surgery. Primary endpoints were patient recovery period, postoperative pain, quality of life and recurrence rate and secondary end points were frequency of complications on the two arms of the trial.
Methods: Sixty consecutive patients with incompetence of the GSV resulting in varicose veins were prospectively randomized into 2 groups of 30, treated by SFJ ligation and either ultrasound-guided foam sclerotherapy or standard stripping of the GSV. The study protocol included history, physical examination, assignment of CEAP class, assessment of the Aberdeen varicose vein questionnaire (AVVQ) and colour Duplex ultrasound.
Results: All treatments were completed as intended. The time taken to complete treatment was shorter in the foam sclerotherapy plus SFJ ligation group as compared to standard stripping: 43 min vs. 65 min (P<0.01, Mann-Whitney). Less analgesic use postoperatively was recorded in the foam sclerotherapy group. Median time to return to normal activities was significantly reduced in the foam sclerotherapy group (3 days) compared to the surgical group (6 days) (P<0.01, Mann-Whitney). The median overall cost of the procedure in the sclerotherapy group was 3143RMB, and was 3638RMB in the conventional surgery (P=0.235, Mann-Whitney). At 3 months, median CEAP class dropped from four preoperatively to one following treatment in both groups (p<0.01, Wilcoxon test). After 6 months, in the foam sclerotherapy group five patients (20%) needed further sessions of foam sclerotherapy, resulting in a short-term closure rate of 80%. And the short-term obliteration rate was 89.5% in the conventional surgery group.
Conclusion: Ultrasound guided sclerotherapy combined with sapheno-femoral ligation involved a shorter treatment time, less postoperative discomfort and resulted in more rapid recovery compared to conventional GSV stripping.