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Systematic Review of the Comparative Effectiveness of Surgical Interventions Aimed at Treating Underlying Venous Pathology in Patients with Chronic Venous Ulcer.
Mahmoud Malas, MD, Umair Qazi, MD, MPH, Gerald Lazarus, MD, M. Fran Valle, Lisa M. Wilson, M.Sc, Elisabeth B. Haberl, Eric B. Bass, MD, MPH, Jonathan Zenilman, M.D.
Johns Hopkins University, Baltimore, MD, USA.
Objectives:
Multi-layer compression dressings are the treatment gold standard for Chronic Venous Ulcers (CVU). Multiple surgical procedures are used to correct the underlying venous pathology but there is no consensus about their efficacy. As part of a larger review, our Evidence-based Practice Center performed a systematic review comparing the effects of surgical therapies for treating CVU on wound-healing rates, time to healing, recurrence rates, mortality, pain, and quality of life.
Methods:
We searched MEDLINE®, EMBASE®, Cochrane Central Register for Controlled Trials, and Cumulative Index for Nursing and Allied Health Literature databases from 1980 to 2012. We included studies comparing a surgical procedure with multi-layer compression therapy or another surgical procedure. We also included studies without a comparison group.
Two independent reviewers screened titles, abstracts, and articles for eligibility, extracted data on study design, applicability, and quality, and graded the strength of the evidence (SOE) after collating the data.
Results:
We reviewed 10,676 citations. We included 22 studies. Eight studies (6 randomized controlled trials {RCT}, 2 cohorts) compared a surgical procedure with compression. Fourteen studies evaluated different surgical interventions.
Adding superficial vein ligation and stripping to compression did not improve wound-healing rate (2 RCTs, RR 0.96, 95% CI, 0.96-1.02).
Recurrence rate was reduced by 50% when surgery corrected the underlying venous pathology (p<0.01, moderate to high SOE).
Adding subfascial endoscopic perforator surgery (2 RCTs) with superficial vein surgery to compression did not improve the healing rate or reduce recurrence rate except for medial and ulcers >2.5cm (HR 0.79, 95% CI, 0.45-1.39, high SOE).
The SOE was insufficient to support a conclusion about:
1. Effects of sclerotherapy when added to compression
2. Surgical treatment for deep venous reflux and venous obstruction
3. Effects of surgical procedures on mortality, pain, and quality of life.
Conclusion:
Our ability to draw conclusions on most surgical techniques was limited due to poorly designed and executed studies, with no uniformity of treatment methods, limited follow-up, poor reporting, and lack of randomization.
We found some evidence to suggest superficial vein ligation and stripping may reduce the risk of wound recurrence, but these techniques are rarely practiced.
The newer minimally invasive techniques lack strong evidence of efficacy. RCTs are needed to determine the efficacy and safety of current endovenous procedures for treating CVU.
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