title: Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein.
abstract: BACKGROUND
  New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared.
  
  
  METHODS
  Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D(™)), adverse events and direct hospital costs.
  
  
  RESULTS
  Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively (P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) (P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping.
  
  
  CONCLUSIONS
  At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 (http://www.clinicaltrials.gov) and NTR654 (http://www.trialregister.nl).
authors.affiliation: Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands. nh.shadid@mumc.nl
authors.forename: N
authors.initials: N
authors.lastname: Shadid
authors.forename: R
authors.initials: R
authors.lastname: Ceulen
authors.forename: P
authors.initials: P
authors.lastname: Nelemans
authors.forename: C
authors.initials: C
authors.lastname: Dirksen
authors.forename: J
authors.initials: J
authors.lastname: Veraart
authors.forename: G W
authors.initials: GW
authors.lastname: Schurink
authors.forename: P
authors.initials: P
authors.lastname: van Neer
authors.forename: J
authors.initials: J
authors.lastname: vd Kley
authors.forename: E
authors.initials: E
authors.lastname: de Haan
authors.forename: A
authors.initials: A
authors.lastname: Sommer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000556:Ambulatory Surgical Procedures / Q000191:economics; D003365:Costs and Cost Analysis; D005260:Female; D017721:Hospital Costs; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000191:economics; D012008:Recurrence; D019233:Retreatment / Q000191:economics; D012501:Saphenous Vein / Q000601:surgery*; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000191:economics; D015911:Sclerotherapy / Q000191:economics / Q000379:methods*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000191:economics / Q000379:methods; D014648:Varicose Veins / Q000191:economics / Q000628:therapy*; D014689:Venous Insufficiency / Q000191:economics / Q000628:therapy
chemical_list: D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols