Abstract
Background: Studies have suggested that Incompetent Perforator Veins (IPV) become competent following High Saphenous Tie and Stripping (HST&S) of the Great Saphenous Vein (GSV). Other studies show an association between IPV and both primary and recurrent varicose veins. The role of Incompetent perforator veins (IPV) in primary non-ulcerated varicose veins has not been established. The aim of this randomised trial was to assess the fate of IPV after HST&S with or without Subfascial Endoscopic Perforator Surgery (SEPS). Also as secondary outcome measures photoplethysmography, quality of life and visual analogue scores were assessed over a 12 month period following surgery. Materials and Methods: Local ethical committee approval was obtained. Inclusion criteria consisted of patients with duplex proven GSV reflux and IPV (reflux > 0. 5 s). Those with deep venous reflux, sapheno-popliteal vein reflux, ulceration and recurrent varicose veins were excluded. Patients were randomly allocated to HST&S alone (NSEPSG) or HST&S plus SEPS (SEPSG). Standardised operations were performed by one of two consultant vascular surgeons. Each patient completed a post-operative diary for 2 weeks (VAS for pain, and mobility, number of pain-killers taken and the amount of daily assistance required). Follow-up assessments were made at 1 week, 6 weeks, 6 months and 1 year. As part of the assessment each subject had repeat Duplex Ultrasound (DU) performed by a single senior vascular technologist. They also filled QOL questionnaires (SF-36 and Aberdeen Questionnaires), underwent Photoplethysmography (PPG), were timed walking a fixed distance, and completed VAS sheets for pain mobility and cosmesis (all also performed pre-operatively). Other data such as risk factors, CEAP classification, body mass index (BMI), family history and number of hours standing were also assessed. The end point of the study was 1 year from the operation. Results: Seventy two patients were recruited (powered to 0.95). Thirty-two were randomised to the NSEPSG (M:F 13:19, mean age 53.4), 38 to SEPSG (M:F=23:15, mean age 53.4). Two patients were excluded, one withdrew and the other was excluded due to undergoing the wrong treatment. The patients in the two groups were similar with respect to the grade of their varicose veins and risk factors. The SEPSG had a significant increase in operative time of 16 minutes which was due to the SEPS procedure. There were no differences in the postoperative diaries filled by the patients. During the follow-up period there were no differences in the two groups with respect to the VAS, QOL assessments, or PPG times. In the NSEPSG there was a significant increase in the number of patients with IPV as assessed by DU at one year (25/32 vs. 12/38 in the SEPSG, P<0.001). Also the majority of these perforators were the same ones seen on the pre-operative DU (37/46 (80%) vs. 5/19 (26%) in SEPSG). Conclusions: IPV do not remain closed following HST and stripping. The addition of SEPS to HST&S increases operative time by an average of 16 minutes and is not associated with increases pain, immobility or cosmetic deterioration. SEPS is effective in treating IPV.