Objective: This Medical Research Council funded trial was set up to investigate whether venous surgery provided any additional benefit in the healing and recurrence rates of venous ulcers over compression bandaging alone. Methods: Ulcer surgery as adjuvant to compression bandaging for leg ulcers (USABLE) was a multicentre, randomized controlled trial, which planned to recruit 1000 venous ulcer patients to receive either compression bandaging alone or compression bandaging plus venous surgery. Follow up recorded ulcer healing, recurrence and patient quality of life. Results: Recruitment was slow, and involved screening a large number of patients (759) with only 75 randomized over an 18-month recruitment period. Conclusions: The results would infer that surgery is unlikely to be a management option for the majority of patients presenting to a hospital with a gaiter area leg ulcer.
on Behalf of the VGST ParticipantsBackground-The purpose of this study was to assess the benefits of duplex compared with clinical vein graft surveillance in terms of amputation rates, quality of life, and healthcare costs in patients after femoropopliteal and femorocrural vein bypass grafts. Methods and Results-This was a multicenter, prospective, randomized, controlled trial. A total of 594 patients with a patent vein graft at 30 days after surgery were randomized to either a clinical or duplex follow-up program at 6 weeks, then 3, 6, 9, 12, and 18 months postoperatively. The clinical and duplex surveillance groups had similar amputation rates (7% for each group) and vascular mortality rates (3% versus 4%) over 18 months. More patients in the clinical group had vein graft stenosis at 18 months (19% versus 12%, Pϭ0.04), but primary patency, primary assisted patency, and secondary patency rates, respectively, were similar in the clinical group (69%, 76%, and 80%) and the duplex group (67%, 76%, and 79%). There were no apparent differences in health-related quality of life, but the average health service costs incurred by the duplex surveillance program were greater by £495 (95% CI £183 to £807) per patient.
Conclusions-Intensive
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