Randomized clinical trial of the effect of adding subfascial endoscopic perforator surgery to standard great saphenous vein stripping

Abstract

This randomized trial was undertaken to investigate the fate of incompetent perforating veins (IPVs) following saphenofemoral ligation and stripping of the great saphenous vein (GSV), with or without subfascial endoscopic perforator surgery (SEPS). Patients with venous reflux (greater than 0.5 s) of the GSV and additional IPVs were allocated randomly to standard surgery (saphenofemoral ligation, stripping and phlebectomies alone) or with the addition of SEPS. Patients with ulceration, recurrent veins, deep venous reflux/thrombosis or saphenopopliteal reflux were excluded. Duplex ultrasonography was carried out before operation, and at 1 week, 6 weeks, 6 months and 1 year after surgery. Quality of life questionnaires were completed and visual analogue scale scores collected at the same time points. Thirty-eight patients were allocated to SEPS and 34 to the no SEPS group. Two patients in the no SEPS group were excluded (one withdrew and the other had the wrong treatment). There were no differences between the two groups with respect to pain, mobility or quality of life scores during follow-up. A significantly higher proportion of patients in the no SEPS group had IPVs on duplex imaging at 1 year (25 of 32 versus 12 of 38; P < 0.001). IPVs do not remain closed following standard varicose vein surgery. The addition of SEPS was not associated with significant morbidity but did reduce the number of IPVs. Up to 1 year this had no effect on recurrence rates or quality of life, but late results remain to be seen. ISRCTN18288048 (http://www.controlled-trials.com).