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A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins - final results of the Venefit versus Clarivein for varicose veins trial

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Title: A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins - final results of the Venefit versus Clarivein for varicose veins trial
Authors: Lane, T
Bootun, R
Dharmarajah, B
Lim, CS
Najem, M
Renton, S
Sritharan, K
Davies, AH
Item Type: Journal Article
Abstract: BACKGROUND: Endovenous thermal ablation has revolutionised varicose vein treatment. New non-thermal techniques such as mechanical occlusion chemically assisted endovenous ablation (MOCA) allow treatment of entire trunks with single anaesthetic injections. Previous non-randomised work has shown reduced pain post-operatively with MOCA. This study presents a multi-centre randomised controlled trial assessing the difference in pain during truncal ablation using MOCA and radiofrequency endovenous ablation (RFA) with six months' follow-up. METHODS: Patients undergoing local anaesthetic endovenous ablation for primary varicose veins were randomised to either MOCA or RFA. Pain scores using Visual Analogue Scale and number scale (0-10) during truncal ablation were recorded. Adjunctive procedures were completed subsequently. Pain after phlebectomy was not assessed. Patients were reviewed at one and six months with clinical scores, quality of life scores and duplex ultrasound assessment of the treated leg. RESULTS: A total of 170 patients were recruited over a 21-month period from 240 screened. Patients in the MOCA group experienced significantly less maximum pain during the procedure by Visual Analogue Scale (MOCA median 15 mm (interquartile range 7-36 mm) versus RFA 34 mm (interquartile range 16-53 mm), p = 0.003) and number scale (MOCA median 3 (interquartile range 1-5) versus RFA 4 mm (interquartile range 3-6.5), p = 0.002). 'Average' pain scores were also significantly less in the MOCA group; 74% underwent simultaneous phlebectomy. Occlusion rates, clinical severity scores, disease specific and generic quality of life scores were similar between groups at one and six months. There were two deep vein thromboses, one in each group. CONCLUSION: Pain secondary to truncal ablation is less painful with MOCA than RFA with similar short-term technical, quality of life and safety outcomes.
Issue Date: 24-May-2016
Date of Acceptance: 27-Apr-2016
URI: http://hdl.handle.net/10044/1/33777
DOI: https://dx.doi.org/10.1177/0268355516651026
ISSN: 1433-3031
Publisher: SAGE Publications
Start Page: 89
End Page: 98
Journal / Book Title: Phlebology
Volume: 32
Issue: 2
Copyright Statement: © The Author(s) 2016. The final, definitive version of this paper has been published in Phlebology by Sage Publications Ltd, All rights reserved. It is available at: http://dx.doi.org/10.1177/0268355516651026.
Sponsor/Funder: Vascular Insight LLC
Funder's Grant Number: PC120430
Keywords: Science & Technology
Life Sciences & Biomedicine
Surgery
Peripheral Vascular Disease
Cardiovascular System & Cardiology
Varicose veins
randomised controlled trial
endovenous ablation
mechanical occlusion chemically assisted ablation
radiofrequency ablation
pain
ENDOVENOUS LASER-ABLATION
GREAT SAPHENOUS VEINS
QUALITY-OF-LIFE
CLINICAL-TRIAL
MECHANOCHEMICAL ABLATION
THERMAL ABLATION
VENOUS DISEASE
GUIDELINES
SCORE
PAIN
1102 Cardiovascular Medicine And Haematology
Cardiovascular System & Hematology
Publication Status: Published
Appears in Collections:Division of Surgery
Faculty of Medicine



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