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Open Access Study protocol

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial

Ramon RJP van Eekeren1, Doeke Boersma2, Suzanne Holewijn1, Anco Vahl34, Jean Paul PM de Vries2, Clark J Zeebregts5 and Michel MPJ Reijnen1*

Author Affiliations

1 Department of Surgery, Rijnstate Hospital, Wagnerlaan 55, Arnhem 6815 AD, The Netherlands

2 Department of Vascular Surgery, St Antonius Hospital, Koekoekslaan 1, Nieuwegein 3435 CM, The Netherlands

3 Department of Surgery, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, Amsterdam 1091 AC, The Netherlands

4 Department of Surgery, BovenIJ Hospital, Statenjachtstraat 1, Amsterdam 1034 CS, The Netherlands

5 Department of Vascular Surgery, University Medical Centre Groningen, University of Groningen, Hanzeplein 1, Groningen 9700 RB, The Netherlands

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Trials 2014, 15:121  doi:10.1186/1745-6215-15-121

Published: 11 April 2014

Abstract

Background

Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain.

Methods/Design

The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base.

Discussion

The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain.

Trial registration

Clinicaltrials NCT01936168

Keywords:
Mechanochemical ablation; ClariVein; Radiofrequency ablation; Varicose vein; Therapy; Treatment; MOCA; Outcome