Elsevier

The Lancet

Volume 363, Issue 9424, 5 June 2004, Pages 1854-1859
The Lancet

Articles
Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial

https://doi.org/10.1016/S0140-6736(04)16353-8Get rights and content

Summary

Background

Chronic venous leg ulceration can be managed by compression treatment, elevation of the leg, and exercise. The addition of ablative superficial venous surgery to this strategy has not been shown to affect ulcer healing, but does reduce ulcer recurrence. We aimed to assess healing and recurrence rates after treatment with compression with or without surgery in people with leg ulceration.

Methods

We did venous duplex imaging of ulcerated or recently healed legs in 500 consecutive patients from three centres. We randomly allocated those with isolated superficial venous reflux and mixed superficial and deep reflux either compression treatment alone or in combination with superficial venous surgery. Compression consisted of multilayer compression bandaging every week until healing then class 2 below-knee stockings. Primary endpoints were 24-week healing rates and 12-month recurrence rates. Analysis was by intention to treat.

Findings

40 patients were lost to follow-up and were censored. Overall 24-week healing rates were similar in the compression and surgery and compression alone groups (65% vs 65%, hazard 0·84 [95% CI 0·77 to 1·24]; p=0·85) but 12-month ulcer recurrence rates were significantly reduced in the compression and surgery group (12% vs 28%, hazard −2·76 [95% CI −1·78 to −4·27]; p<0·0001). Adverse events were minimal and about equal in each group.

Interpretation

Surgical correction of superficial venous reflux reduces 12-month ulcer recurrence. Most patients with chronic venous ulceration will benefit from the addition of simple venous surgery.

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

References (30)

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