ArticlesComparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial
Introduction
Chronic venous ulceration affects 1–2% of the population and usually has a protracted course of healing and can recur many times.1, 2 This disorder accounts for about 1% of the total health costs of developed countries.3
Multilayer elastic compression bandaging, leg elevation, and exercise—within specialist-nurse led clinics—achieve healing rates for this disorder of 68–83% at 24 weeks.1, 4, 5 However, despite prescription of elastic compression stockings, 12-month ulcer recurrence rates of 26–28%2, 5, 6 have been reported and can be as high as 69%.7 Conservative treatments do little to address underlying abnormal venous function. Visible varicosities are only present in about 40% of patients with superficial venous reflux,8 but findings of duplex ultrasonography studies in legs with chronic venous ulceration have shown that 51–53% have reflux in the superficial system alone, 32–44% reflux in both superficial and deep venous systems, and 5–15% reflux in the deep venous system alone.9, 10
Simple superficial venous surgery—ie, saphenous vein ablation—theoretically removes underlying venous incompetence in legs with isolated superficial venous reflux. In a non-randomised study, patients with isolated superficial venous reflux undergoing compression therapy alone were compared with those having compression treatment and superficial venous surgery.5 Surgery did not confer any additional benefit in terms of venous ulcer healing, but recurrence was significantly reduced from 28% to 14% at 12 months. In a small, randomised controlled trial in patients with isolated superficial reflux, the ulcer recurrence rate at 3 years was 9% in those treated with surgery compared with 38% in those treated with compression.11
Coexistent deep venous reflux can include all or some deep venous segments of the leg and is termed total or segmental deep reflux, respectively.12 In a few small studies, reduced ulcer recurrence has been reported after superficial venous surgery in legs with mixed superficial and segmental deep reflux.13, 14
Surgery to correct venous reflux in the deep veins is complex and of unproven value.15 Subfascial endoscopic perforator surgery has been widely described in the management of chronic venous ulceration but is usually used in combination with simple superficial venous surgery.16, 17, 18 Perforator vein surgery should be reserved for the few (2–3%) legs with isolated calf perforator incompetence.9, 19
We aimed to assess the effect of surgery and compression on healing and recurrence (ESCHAR study).
Section snippets
Patients
The target population consisted of consecutive patients presenting with leg ulceration to vascular services in Gloucestershire and north Bristol, UK, between January, 1999, and August, 2002. We accepted direct referrals from family doctors, community and practice nurses, and other medical specialists. Patients were seen in a one-stop assessment clinic, which incorporated clinical history and examination, anklebrachial pressure index, and colour venous duplex imaging. Venous segments were
Results
1418 consecutive patients with a history of chronic leg ulceration were assessed for inclusion. 265 eligible patients did not consent to the study because they were unwilling to consider a surgical intervention, which could not be guaranteed as superior to conservative measures alone. 500 eligible patients consented to the study and were randomly allocated between the two treatment arms (figure 1). 300 (60%) patients were recruited with isolated superficial reflux, 126 (25%) had mixed
Discussion
We have shown that ulcer healing at 24 weeks is not enhanced by superficial venous surgery, possibly because the haemodynamic effect of conservative interventions are as great as the combination of superficial venous surgery plus compression. The target ankle pressure from multilayer bandaging is 40 mm Hg. Class 2 compression stockings only produce ankle pressures of 18–24 mm Hg. This drop in ankle pressure could partly account for the failure of conservative measures alone to provide long-term
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