Long Term Results of Compression Therapy Alone Versus Compression Plus Surgery in Chronic Venous Ulceration (ESCHAR): Randomised Controlled Trial

BMJ. 2007 Jul 14;335(7610):83. doi: 10.1136/bmj.39216.542442.BE. Epub 2007 Jun 1.

Abstract

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].

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Chronic Disease
  • Combined Modality Therapy / methods
  • Disease-Free Survival
  • Female
  • Humans
  • Male
  • Middle Aged
  • Secondary Prevention
  • Stockings, Compression*
  • Treatment Outcome
  • Varicose Ulcer / therapy*
  • Vascular Surgical Procedures / methods*
  • Wound Healing

Associated data

  • ISRCTN/ISRCTN07549334