A multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins

초록

Objective: The treatment of varicose veins has shifted from conventional surgical stripping (SS) to minimally invasive endovenous modalities. Cyanoacrylate closure (CAC) with the VenaSeal system (Medtronic, Dublin, Ireland) has increased in popularity owing to its nonthermal and nontumescent technique. The purpose of the present study was to compare the clinical outcomes of CAC and SS for the treatment of incompetent great saphenous veins. Methods: An open-label, multicenter, prospective, randomized controlled trial was conducted. The subjects were ran-domized to either the CAC or SS procedure. The primary endpoint of the present study was to evaluate complete closure of the target vein at 3 months. Target vein occlusion was assessed on the third day and 1, 3, 6, and 12 months post-operatively using duplex ultrasound. The pain and ecchymosis grades were also assessed. Additionally, the clinical out -comes, such as the venous clinical severity score and Aberdeen Varicose Vein Questionnaire score, were assessed. Results: Three-month follow-up data were obtained for all 126 enrolled and randomized subjects (63 with CAC and 63 with SS). At 3 months, complete target vein closure was observed in both groups. The postoperative pain score was significantly better in the CAC group than in the SS group (0.3 +/- 0.6 in the CAC group and 1.1 +/- 1.5 in the SS group; P < .001). In addition, the mean ecchymosis grade was 0.3 +/- 0.5 in the CAC group and 1.1 +/- 1.1 in the SS group (P < .001). The venous clinical severity score and quality of life had improved equally in both groups. The adverse events after both procedures were mostly minor complications (9 events in CAC group and 20 events in SS group). Major complications occurred in one patient who had undergone the SS procedure. Conclusions: The CAC and SS procedures were both associated with complete occlusion of the target vein at 3 months. The postoperative pain and ecchymosis grades were significantly lower in the CAC group. Other differences between the two groups included the frequency and nature of the complications. The results showed that CAC has high success with few complications.

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