Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trialBMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39216.542442.BE (Published 12 July 2007) Cite this as: BMJ 2007;335:83
- Manjit S Gohel, specialist registrar1,
- Jamie R Barwell, consultant vascular and transplant surgeon2,
- Maxine Taylor, leg ulcer nurse specialist1,
- Terry Chant, vascular nurse specialist3,
- Chris Foy, medical statistician4,
- Jonothan J Earnshaw, consultant surgeon5,
- Brian P Heather, consultant surgeon5,
- David C Mitchell, consultant surgeon3,
- Mark R Whyman, consultant surgeon1,
- Keith R Poskitt, consultant surgeon1
- 1Cheltenham General Hospital, Cheltenham, Gloucester GL53 7AN
- 2Derriford Hospital, Plymouth
- 3Southmead Hospital, Bristol
- 4Gloucestershire Hospitals NHS Trust, Gloucester
- 5Gloucestershire Royal Hospital, Gloucester
- Correspondence to: K R Poskitt
- Accepted 26 April 2007
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.
We thank for their support and assistance CE Davies, G Turton, G Woolfrey, J Waldron (Gloucestershire Leg Ulcer Service); C Wakely, J Minor, K Harvey, A Sassano (vascular scientists); and B Whitman (research assistant).
Contributors: MG was involved with data acquisition, management and analysis, and wrote this report. JB, JE, MW, and KP were involved with study concept and design, performed surgery, and critically revised this report. BH and DM performed surgery, were involved with data acquisition, and critically revised this report. MT, TC were involved with data acquisition, and critically revised this report. CF provided statistical guidance and critically revised this report.
Funding: NHS Executive South and West Research and Development Directorate, Southmead Hospital Research Foundation, and Medical Research Council. The funding sources had no financial or other interest in study outcome and had no role in study design, data control or reporting.
Competing interests: None declared.
Ethical approval: Gloucestershire and Southmead research ethics committees.
- Accepted 26 April 2007