title: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials NCT01936168.
authors.forename: Ramon R J P
authors.initials: RR
authors.lastname: van Eekeren
authors.forename: Doeke
authors.initials: D
authors.lastname: Boersma
authors.forename: Suzanne
authors.initials: S
authors.lastname: Holewijn
authors.forename: Anco
authors.initials: A
authors.lastname: Vahl
authors.forename: Jean Paul p m
authors.initials: JP
authors.lastname: de Vries
authors.forename: Clark J
authors.initials: CJ
authors.lastname: Zeebregts
authors.affiliation: Department of Surgery, Rijnstate Hospital, Wagnerlaan 55, Arnhem 6815 AD, The Netherlands. mmpj.reijnen@gmail.com.
authors.forename: Michel M P J
authors.initials: MM
authors.lastname: Reijnen
mesh_terms: D000203:Activities of Daily Living; D000758:Anesthesia; D017115:Catheter Ablation / Q000009:adverse effects / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D057510:Endovascular Procedures / Q000009:adverse effects / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D009426:Netherlands; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D062707:Return to Work; D012501:Saphenous Vein / Q000601:surgery*; D015911:Sclerotherapy / Q000009:adverse effects / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D014689:Venous Insufficiency / Q000175:diagnosis / Q000191:economics / Q000601:surgery / Q000628:therapy*
references.citation: Ann Vasc Surg. 2010 Apr;24(3):360-6
references.pmid: 20116207
references.citation: Br J Surg. 1994 Oct;81(10):1455-8
references.pmid: 7820469
references.citation: J Vasc Surg. 2011 Jul;54(1):146-52
references.pmid: 21439757
references.citation: Ann R Coll Surg Engl. 2003 Jan;85(1):52-7
references.pmid: 12585635
references.citation: J Epidemiol Community Health. 1999 Mar;53(3):149-53
references.pmid: 10396491
references.citation: J Endovasc Ther. 2011 Jun;18(3):328-34
references.pmid: 21679070
references.citation: Phlebology. 2014 Jul;29(6):397-400
references.pmid: 23820117
references.citation: Phlebology. 2012 Mar;27(2):67-72
references.pmid: 21803800
references.citation: Mayo Clin Proc. 1996 Apr;71(4):338-45
references.pmid: 8637255
references.citation: J Vasc Surg. 2000 Jun;31(6):1307-12
references.pmid: 10842165
references.citation: Eur J Vasc Endovasc Surg. 2010 Aug;40(2):246-53
references.pmid: 20537570
references.citation: Br J Surg. 2011 Aug;98(8):1079-87
references.pmid: 21725957
references.citation: Eur J Vasc Endovasc Surg. 2009 Feb;37(2):232-8
references.pmid: 18993090
references.citation: Phlebology. 2008;23(3):103-11
references.pmid: 18467617
references.citation: BMJ. 2006 Aug 5;333(7562):287-92
references.pmid: 16888305
references.citation: J Endovasc Ther. 2009 Aug;16(4):500-5
references.pmid: 19702351
references.citation: Br J Surg. 2010 Jun;97(6):810-8
references.pmid: 20473992
references.citation: Vasc Endovascular Surg. 2010 Apr;44(3):212-6
references.pmid: 20150227
references.citation: Ann R Coll Surg Engl. 1997 Mar;79(2):105-10
references.pmid: 9135236
references.citation: Br J Surg. 2010 Mar;97(3):328-36
references.pmid: 20035541
references.citation: Br J Surg. 1994 Feb;81(2):167-73
references.pmid: 8156326
references.citation: Cardiovasc Surg. 2000 Jun;8(4):233-45
references.pmid: 10950599
references.citation: J Vasc Surg. 2013 Feb;57(2):445-50
references.pmid: 23141679
references.citation: J Clin Epidemiol. 2003 Feb;56(2):171-9
references.pmid: 12654412
references.citation: Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303
references.pmid: 23312507
references.citation: Phlebology. 2009;24 Suppl 1:34-41
references.pmid: 19307439
references.citation: J Vasc Surg. 2008 Sep;48(3):680-7
references.pmid: 18586443
references.citation: J Vasc Surg. 2009 Jan;49(1):230-9
references.pmid: 18692348