Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial

Отдаленные результаты одной компрессионной терапии по сравнению с компрессионной терапией в сочетании с хирургическим вмешательством при хронических венозных язвах (ESCHAR): рандомизированное контролируемое исследование
Manjit Gohel, Jamie Barwell, M. Taylor, Terry Chant, Chris Foy, J J Earnshaw, Brian P Heather, David C. Mitchell, M R Whyman, K R Poskitt
2007-06-01

compression therapyrandomised controlled trialsaphenous surgerysuperficial venous refluxvenous ulcer recurrence
OBJECTIVE: To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression. DESIGN: Randomised controlled trial. SETTING: Specialist nurse led leg ulcer clinics in three UK vascular centres. PARTICIPANTS: 500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux. INTERVENTIONS: Compression alone or compression plus saphenous surgery. MAIN OUTCOME MEASURES: Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time. RESULTS: Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test). CONCLUSION: Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time. TRIAL REGISTRATION: Current Controlled Trials ISRCTN07549334 [controlled-trials.com].
1
Adding saphenous surgery to compression did not significantly improve three-year ulcer healing rates (93% versus 89%; P=0.73).
2
Compression plus surgery significantly reduced four-year ulcer recurrence compared with compression alone (31% versus 56%; P<0.01).
3
Patients receiving compression plus surgery had more ulcer-free time after three years than those receiving compression alone (78% versus 71%; P=0.007).
4
Recurrence reduction was significant for isolated superficial reflux and superficial plus segmental deep reflux, but not for total deep reflux.
5
Surgical correction of superficial venous reflux provides long-term recurrence prevention and more ulcer-free time, without improving initial ulcer healing.

Chronic leg ulcers associated with superficial venous reflux

Ulcer healing, recurrence, and ulcer-free time under compression therapy alone versus compression combined with surgical correction of superficial venous reflux

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2007-06-01
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Manjit Gohel
Jamie Barwell
M. Taylor
Terry Chant
Chris Foy
J J Earnshaw
Brian P Heather
David C. Mitchell
M R Whyman
K R Poskitt
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