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

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.

• Authors: Ramon R J P van Eekeren, Doeke Boersma, Suzanne Holewijn, Anco Vahl, Jean Paul p m de Vries, Clark J Zeebregts, Michel M P J Reijnen
• Journal: Trials (Trials) Vol. 15 Pg. 121 (Apr 11 2014) ISSN: 1745-6215 [Electronic] England
• PMID: 24726004 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Activities of Daily Living
• Anesthesia
• Catheter Ablation (adverse effects, economics)
• Clinical Protocols
• Cost-Benefit Analysis
• Endovascular Procedures (adverse effects, economics)
• Health Care Costs
• Humans
• Netherlands
• Pain Measurement
• Pain, Postoperative (etiology, prevention & control)
• Prospective Studies
• Quality of Life
• Recovery of Function
• Research Design
• Return to Work
• Saphenous Vein (surgery)
• Sclerotherapy (adverse effects, economics)
• Time Factors
• Treatment Outcome
• Venous Insufficiency (diagnosis, economics, surgery, therapy)