Prospective Randomized Study of Ultrasound-Guided Foam Sclerotherapy Combined with Great Saphenous Vein High Ligation in the Treatment of Severe Lower Extremity Varicosis

Abstract

To evaluate the effect of ultrasound-guided foam sclerotherapy (UGFS) in a single session combined with great saphenous vein (GSV) high ligation for severe lower extremity varicosis classified as C4-C6, compared with GSV stripping plus multistab avulsion or transilluminated powered phlebectomy (TIPP). From January 2012 to December 2014, 177 patients with primary GSV insufficiency, classified as C4-C6, were randomized into the UGFS group or the control group. The UGFS group was managed by GSV high ligation and foam sclerotherapy in one session under the surveillance of ultrasonography, whereas the control group received GSV high ligation and stripping combined with multistab avulsion or TIPP. The patients were followed up at 1, 6, and 12months after treatment. Outcome assessments included reflux recurrence rate, procedure-related adverse events, hemodynamic parameters, revised Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ) score. The medical cost and operating time of the 2 groups were also compared. In total, 73 patients received UGFS, whereas 90 patients underwent traditional surgery. Sixty-five patients in the UGFS group (89.0%) and 74 patients in the control group (82.2%) completed the follow-up. At the end of 12months, the cumulative refluxrecurrencerate was 13.8% in the UGFS group and 13.5% in the control group (P=0.955). In the UGFS and control groups, minor complications (27.7% vs. 21.6%, P=0.406) and major complications (3.1% vs. 2.7%, P=0.895) were not significantly different. Compared with baseline values, obvious improvements of the venous filling index, VCSS, and AVVQ scores after treatment were confirmed in both groups (P<0.001). The average operating and recovery times were much shorter (38.3 vs. 81.2min, 5.4 vs. 9.6days, P<0.001, respectively), and the average hospital cost was much lower ($853 vs. $1,575, P<0.001) in the UGFS group than in the control group. The patient satisfaction rate reached 92.3% in the UGFS group and 89.2% in the control group 12months after operation (P=0.270). Our outcomes indicated that UGFS combined with GSV high ligation was safe and effective for severe lower extremity varicosis.