Methods
vascular malformation, reflux, agenesis, CVD, ankle, post-thrombotic syndrome, AASV, SVT
SVT, REFLUX, CVD, INCOMPETENCE, VARICOSE VEINS, BLIND, SUPERFICIAL VEIN THROMBOSIS, ARTERIAL INSUFFICIENCY
Patients with CVD referred to seven medical centres in the Netherlands were screened for eligibility. Eligible were adults (aged at least 18 years) with symptoms of CVD, clinically obvious varicose veins (clinical class at least C2, according to the Clinical Etiologic Anatomic Pathophysiologic (CEAP) classificationExclusion criteria were: bilateral GSV or AASV incompetence, previous treatment of the ipsilateral GSV (in the case of the AASV, previous treatment of the ipsilateral AASV) or tributaries, incompetence of the GSV or AASV in the same leg, previous ipsilateral high ligation of the SFJ, acute deep or superficial vein thrombosis (SVT), agenesis of the deep venous system or any other vascular malformation, post-thrombotic syndrome, pregnancy, immobility, arterial insufficiency (ankle : brachial pressure index below 0.6), or inability to understand the patient information leaflets and questionnaires.Included patients were randomized to either the SAP group, in which patients received only ambulatory phlebectomy, or the TAP group, in which patients underwent combined endovenous laser ablation (EVLA) and phlebectomy. Additional treatment was considered in the SAP group if symptomatic patients showed persisting GSV/AASV reflux at 9 months’ follow-up. Patients were randomized using an automated randomization service operated by Erasmus Clinical Trial Centre, stratified by the medical centre.Because of the technical differences in treatment procedures, it was not possible to blind the treating physicians. Owing to the noises and the materials used, and the typical side-effects that occur during or after the EVLA (barbecue taste in the mouth and burning sensation over the treated segment), blinding of the patients was also not possible. Assessors were not blinded for practical reasons.All patients signed an informed consent form, after having received all the specific information regarding the SAPTAP trial. Patients randomized to the SAP group agreed to have an extra follow-up evaluation after 9 months and, if necessary, additional EVLA or an alternative treatment of the GSV or AASV.