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


RESULTS
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.


CONCLUSIONS
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.
Barwell
Jamie R
JR
Department of Vascular Surgery, Cheltenham General Hospital, Cheltenham GL53 7AN, UK.
Davies
Colin E
CE
Deacon
Jane
J
Harvey
Kate
K
Minor
Julia
J
Sassano
Antonio
A
Taylor
Maxine
M
Usher
Jenny
J
Wakely
Clare
C
Earnshaw
Jonathan J
JJ
Heather
Brian P
BP
Mitchell
David C
DC
Whyman
Mark R
MR
Poskitt
Keith R
KR
D000368:Aged; D000369:Aged, 80 and over; D001458:Bandages; D002908:Chronic Disease; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012008:Recurrence; D012501:Saphenous Vein / Q000601:surgery; D018615:Ultrasonography, Doppler, Color; D014647:Varicose Ulcer / Q000601:surgery / Q000628:therapy*; D014680:Veins / Q000601:surgery*; D014689:Venous Insufficiency / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery