title: Same Site Recurrence is More Frequent After Endovenous Laser Ablation Compared with High Ligation and Stripping of the Great Saphenous Vein: 5 year Results of a Randomized Clinical Trial (RELACS Study).
abstract: OBJECTIVE
  To compare the long-term clinical efficacy of endovenous laser ablation (EVLA) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) incompetence.
  
  
  METHODS
  Investigator initiated two centre randomized controlled trial with 5 year follow up.
  
  
  METHODS
  Interventions were performed on ambulatory and hospitalized patients at two vein centres, a university dermatology department (EVLA) and a specialized vein clinic (HLS). Four hundred patients suffering from GSV incompetence were assigned to EVLA or HLS of the GSV. One hundred and eighty five and 161 patients (=limbs), respectively, were treated per protocol. Main outcome measures were clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), Duplex detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), quality of life (Chronic Venous Insufficiency Questionnaire 2), side effects, and patient satisfaction 5 years after treatment.
  
  
  RESULTS
  Two hundred and eighty one legs (81% of the study population) were evaluated with a median follow up of 60.4 (EVLA) and 60.7 months (HLS). Overall, REVAS was similarly observed in both groups: 45% (EVLA) and 54% (HLS), p = .152. Patients of the EVLA group showed significantly more clinical recurrences in the operated region (REVAS: same site): 18% vs. 5%, p = .002. In contrast, more different site recurrences were observed in the HLS group: 50% vs. 31%, p = .002. Duplex detected saphenofemoral refluxes occurred more frequently after EVLA: 28% vs. 5%, p < .001. Both treatments improved disease severity and quality of life without any difference.
  
  
  CONCLUSIONS
  EVLA and HLS are comparably effective concerning overall REVAS, improvement of disease severity, and quality of life. In terms of same site clinical recurrence and saphenofemoral refluxes, HLS is superior to EVLA 5 years after treatment.
  
  
  BACKGROUND
  ISRCTN18322872.
authors: Department of Dermatology, Venerology and Allergology, Saarland University Hospital, Homburg, Germany; Eifelklinik St. Brigida, Vein and Skin Centre, Simmerath, Germany. Electronic address: knuth.rass@st-brigida.de.
authors: K
authors: K
authors: Rass
authors: Capio Mosel-Eifel-Klinik, Clinic for Vein Disorders, Bad Bertrich, Germany.
authors: N
authors: N
authors: Frings
authors: Capio Mosel-Eifel-Klinik, Clinic for Vein Disorders, Bad Bertrich, Germany.
authors: P
authors: P
authors: Glowacki
authors: Institute of Medical Biometry, Epidemiology and Medical Informatics, Saarland University Hospital, Homburg, Germany.
authors: S
authors: S
authors: Gräber
authors: Department of Dermatology, Venerology and Allergology, Saarland University Hospital, Homburg, Germany.
authors: W
authors: W
authors: Tilgen
authors: Department of Dermatology, Venerology and Allergology, Saarland University Hospital, Homburg, Germany.
authors: T
authors: T
authors: Vogt
mesh_terms: D000293:Adolescent; D000328:Adult; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D005268:Femoral Vein; D006801:Humans; D053685:Laser Therapy; D008026:Ligation; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012008:Recurrence; D012501:Saphenous Vein / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome; D014648:Varicose Veins / Q000601:surgery*; D055815:Young Adult
keywords: Endovenous laser ablation; Great saphenous vein; High ligation and stripping; Long-term efficacy; Randomized controlled trial; Varicose vein recurrence