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Early Results of A Randomised Clinical Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins (MOCCA)

Journal of vascular surgery Venous and lymphatic disorders(2019)

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摘要
Introduction: Endovenous thermal ablation techniques have become the first line treatment of truncal veins. However, these techniques use heat and have need of tumescent anaesthesia which are often associated with pain. To overcome these side effects, novel non-thermal techniques such as mechanochemical ablation (MOCA) and cyanoacrylate embolization (CAE) have been developed; these do not require tumescence nor use heat. This randomized control trial is aimed at assessing the degree of pain resulting from MOCA compared with CAE. We are herein reporting the early results of this randomised clinical trial Methods: Patients with saphenous vein incompetence were randomised to receive treatment with either MOCA or CAE. The primary end point is pain score immediately following completion of truncal ablation, measured by a 100mm visual analogue scale (VAS). The secondary end points include entire treatment pain scores, clinical scores and quality of life scores. Additional assessments also include ecchymosis scores, occlusion rates, time to return to usual activities/work at two weeks. Patients are reviewed at 2 weeks, 3 months, 6 months and 12 months Results: Eighty-four patients have been recruited so far (66% women with mean age 56 years). The vein treated was the great saphenous vein (GSV) in 86% of cases and 51% of the cases were randomised to cyanoacrylate ablation. Both groups had similar baseline characteristic. Patients in both groups experienced similar maximum pain score by VAS (CAE median 24 mm (IQR 9-45) versus MOCA median 23 mm (IQR 11-49); p = 0.464) and number scale (CAE median 3 (IQR 1-5) versus MOCA median 3 (IQR 2-5); p = 0.333). Average pain score was also similar between treatment groups. Eighty-three per cent (70 patients) of the population attended the 2-week follow-up. Post-procedure ecchymosis score, recovery time, clinical and quality of life scores were similar between groups. Conclusion: The early results of this trial showed that pain score is comparable between CAE and MOCA endovenous ablation. The results also indicated similar improvement in the quality of life, clinical improvement and recovery time. Recruitment of patients is ongoing, and longer-term follow-up data are currently being collected. Disclosure: Nothing to disclose
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关键词
Endovenous Treatment,Varicose Veins
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