Randomized clinical trial of varicose vein surgery with compression versus compression alone for the treatment of venous ulceration

Abstract

Objectives: No randomized controlled trials exist to show whether varicose vein surgery improves healing of venous ulcers. In this study we investigated whether superficial venous surgery gave additional benefit to compression therapy in terms of healing rate, time to healing and quality of life of patients with venous ulcers. Methods: A total of 121 consecutive patients with venous ulceration were identified, of which 45 were unfit/unwilling to be included. The remaining 76 (aged 38-89, 39 female) were randomized to receive either four-layer bandaging ( n =39) or superficial venous surgery (long and short saphenous with or without perforator surgery) and four-layer bandaging ( n =37). Ulcer healing and health-related quality of life (HRQL) were assessed. Results: The healing rate was 64% (25/39) in the compression treatment group and 68% (25/37) in the surgical treatment group. This difference was not statistically significant (Pearson 2 P=0.75). There was no significant difference between the time to ulcer healing in the two treatment groups (log rank statistic=0.69, P value=0.41): median time 83 days for surgery vs 98 days for compression. After adjusting for duration of ulcer, size of ulcer and previous deep vein thrombosis, there was still no significant difference between time to healing for the two treatment groups (adjusted hazard ratio=0.79, 95% confidence interval 0.45-1.39). There was no difference in HRQL between the two groups, using the scores of a disease-specific questionnaire (CXVUQ). Conclusions: This study suggests that for venous ulceration, superficial venous surgery gives no additional benefit to compression therapy from the point of view of healing rate and quality of life.

A Prospective Study in Comparison of Ambulatory Phlebectomy and Duplex Guided Foam Sclerotherapy in the Management of Varicosities with Isolated Perforator Incompetence

“…In the recent years, compression therapy has transitioned from primarily undergoing evaluation to comparison of compression therapy alone versus other modalities of treatment. Zamboni et al [9] and Guest et al [10] showed that the effectiveness of compression therapy is 96 and 68 %, respectively, in patients with venous ulcers due to major superficial venous incompetence, and their results are comparable to minimal invasive procedures. But compression therapy alone ironically did not produce satisfactory results in most of the patients with isolated perforator incompetence though it had been proven to be good in major venous incompetence.…”

Systematic review of topic treatment for venous ulcers

“…The compression therapy must be consistently applied in order improve the care effectiveness and reduce treatment cost (11,24) . Professionals who use the system must be trained (15) , since inadequate application of compression can lead to complications.…”

“…The four studies on compressive therapy with a descriptive-exploratory design proposed to: evaluate the relation between the pattern of venous incompetence and wound healing in patients using fourlayer compression bandages (24) ; determine the healing rate and cost of compression therapy (25) ; determine the healing rate with the use of the four-layer compression bandage system, Charing Cross (26) and evaluate the efficacy of the four-layer bandage system, Parema (27) . The study samples varied from 50 to 438 subjects and one counted 198 legs as a sample.…”

Medical and surgical treatment of chronic venous ulcers

“…[20][21][22] Four RCTs compared surgery for perforator vein reflux to compression and found similar rates of complete ulcer healing. [23][24][25][26] There was improved quality of life, a faster rate of healing (31 days vs. 63 days, p<0.02) and lower ulcer recurrence rate (9% vs. 38%; p<0.05) with ligation of saphenous vein tributaries than with compression alone. 23 Another RCT comparing the effectiveness of sclerotherapy with compression alone found a faster rate of ulcer healing in the surgery arm (mean of 8 vs. 20 weeks, p<0.05).…”