Meta-analysis of nontumescent-based versus tumescent-based endovenous therapies for patients with great saphenous insufficiency and varicose veins
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OBJECTIVE: The objective of this study was to compare the nontumescent-based endovenous therapies with the standard tumescent-based endovenous therapies in regard to clinical effectiveness and procedural outcomes in patients with saphenofemoral incompetence and varicose veins. METHODS: The following databases were searched for studies that were randomized or quasi-randomized trials comparing nontumescent-based endovenous procedures with those requiring tumescence: Cochrane Central Register of Controlled Trials (1950-January 2017), MEDLINE (1946-January 2017), and Embase (1950-January 2017). There were no restrictions based on language or publication status. In the case of ongoing studies, the World Health Organization's International Clinical Trials Registry Platform and the online ClinicalTrials.gov registry were also searched. We also reviewed reference lists of articles relevant to our study to ensure a more complete review. Two authors independently screened and selected studies to be included. These two authors also independently assessed the risk of bias using the Cochrane risk of bias tool. Data were extracted and pooled using a random-effects model. RESULTS: A total of nine studies were found in the literature search, of which five were included in analysis. Four outcomes were reviewed. A significant difference was found between the comparator groups for mean intraprocedural pain score (effect estimate, -0.66), favoring nontumescent-based therapies. There was no difference for Venous Clinical Severity Score (effect estimate, -0.21) for clinical assessment and the Aberdeen Varicose Vein Questionnaire score (effect estimate, 0.27) for the disease-specific quality of life between the groups. The outcome of failure of truncal ablation at 30 days had no significant difference between the groups (risk ratio, 1.27), although a subgroup analysis demonstrated a trend toward improved results with the novel nontumescent-based treatments (risk ratio, 0.21) compared with the old nontumescent-based treatments (risk ratio, 8.6). CONCLUSIONS: Currently available evidence from reasonable-quality clinical trials comparing tumescent-based with non-tumescent-based endovenous therapies shows no overall difference between the groups on a number of outcomes. Mean intraprocedural pain score appears to favor nontumescent-based interventions. Newer randomized trials comparing the treatment modalities are needed to further clarify the benefits of nontumescent-based therapies, particularly with regard to long-term outcomes.