Up to 2 percent of the population has chronic venous ulceration. These ulcers usually follow a protracted course. Aggressive management by specialist nurses using multilayer elastic compression bandaging, leg elevation, and exercise can heal 68 to 83 percent of ulcers within 24 weeks; however, even with follow-up care, 26 to 69 percent of lesions recur within one year. Surgical correction of underlying venous pathology has been advocated, because at least one half of these patients have reflux in the superficial venous system, up to 15 percent have it in the deep venous system, and 32 to 44 percent have it in both systems. Because small studies of different surgical treatments have not shown any substantial benefit, Barwell and colleagues conducted a randomized study of the value of adding surgery to compression therapy for treatment of chronic venous ulcers.
They studied patients in an English region who were referred to vascular services because of leg ulceration between 1999 and 2002. After comprehensive assessment, patients in whom compression therapy was not practical or complete color duplex imaging could not be achieved, and those unfit for surgery were excluded from the study. Patients with occluded deep veins also were excluded.
The remaining 500 patients who consented to the study were randomly assigned to compression therapy alone or to compression therapy plus surgery. The randomization was stratified to adjust for superficial, deep, or mixed venous reflux. The primary outcomes studied were ulcer healing at 24 weeks and rates of recurrence in the following 12 months. Assessors could not be blinded because of surgical scars. All compression bandaging was performed by specialist nurses and community nurses (on a shared-care basis) using a standard technique. Elastic stockings were used once ulcers had healed. Surgical intervention was based on the findings of color duplex imaging. Patients were reviewed at ulcer clinics every month until healed and then at one, three, six, nine, and 12 months, with annual follow-ups for at least five years. Quality-of-life assessments also were completed initially and at six and 12 months.
Forty patients were lost to follow-up; of those allocated to surgery, 47 refused the procedures offered, and three of those assigned to compression alone demanded surgery. Data were available on 156 active plus 86 recently healed ulcers treated with compression and surgery. In the group treated with compression alone, data were available on 185 active plus 73 recently healed ulcers. The patients receiving both treatments were similar in demographic and clinical characteristics, with the exception that diabetes mellitus was twice as prevalent (10 percent) in the compression group as in the group also offered surgery (5 percent).
At 24 weeks, the rate of healing was 65 percent in both groups. Subgroup analysis failed to reveal significant differences between the two treatment groups. Patients with recently healed ulcers at onset were included in the study of recurrence. At 12 months, the recurrence rate was significantly lower in patients treated by compression plus surgery (12 percent compared with 28 percent). This difference persisted after adjustment for diabetes. Subgroup analysis showed that the greatest benefit was derived from combined surgical and compression therapy in patients with isolated superficial reflux and those with superficial plus segmental deep reflux. Adverse events were uncommon. Nine of the 258 patients treated with compression had cellulitis or cutaneous damage. Five surgical patients had wound infections, and an additional five patients had other complications such as phlebitis, hematoma, cutaneous damage, or deep venous thrombosis.
The authors conclude that ulcer healing is not enhanced by the addition of surgery, but rates of ulcer recurrence are significantly improved. They calculate that five surgeries are necessary to prevent one ulcer recurrence at 12 months. They recommend that patients who are willing to undergo surgery and are good surgical candidates be assessed with venous duplex imaging and offered appropriate surgical interventions to prevent ulcer recurrence.