title: [Two-year results of a prospective randomised controlled multicenter trial to compare open operative therapy vs. endoluminal venous laser therapy with and without high ligation for the therapy of varicose greater saphenous veins].
abstract: BACKGROUND
  Therapeutic options for the treatment of varicosis of the great saphenous vein (gsv) include endoluminal laser therapy, crossectomy/stripping and a combination of both. In this paper we present data for clinical and sonographic inguinal recurrencies up to two years post operation.
  
  
  METHODS
  In an open multicentre, randomised three-arm trial, sonographic and clinical parameters were compared perioperatively, after 2, 6, 12 and 24 months between endoluminal venous laser therapy, high ligation and invaginating stripping and a combination of both (laser: 980 nm, continuous mode, 30 W, Biolitec®, Jena, Germany). Data of 449 patients were available for the perioperative and 2 months examination. 388 patients were followed up until 6, 380 patients for 12 and 332 patients for 24 months. We compared clinical recurrences, sonographic reflux findings, and reflux side branches in the inguinal region at the saphenofemoral junction.
  
  
  RESULTS
  We found significantly more inguinal reflux and reflux side branches in the laser groups (p < 0.0001), however, there was no statistically significant relation between clinical recurrences and sonographic reflux. Over time, there were no intraindividual constant refluxes. Regarding the secondary endpoints oedema, lymphatic oedema, local disturbances of sensibility and irritations of the saphenous nerve, lymphatic oedema and irritations of the saphenous nerve were significantly more present in the two laser groups. After two years pain and restrictions in professional life were no longer relevant in all groups.
  
  
  CONCLUSIONS
  Clinical recurrences developed both in the C/S and in the laser group but reflux into the gsv and into proximal side branches developed significantly more often in the laser group. In a long-term follow-up we have to investigate the importance of reflux side branches for the development of clinical recurrences to reveal differences between the three therapeutic strategies.
authors.affiliation: Klinik für Gefäßmedizin, Helios Klinikum Emil von Behring, Berlin, Deutschland.
authors.forename: I H
authors.initials: IH
authors.lastname: Flessenkämper
authors.affiliation: Venenzentrum Saarlouis, Deutschland.
authors.forename: D
authors.initials: D
authors.lastname: Stenger
authors.affiliation: Venenzentrum Freiburg, Deutschland.
authors.forename: M
authors.initials: M
authors.lastname: Hartmann
authors.affiliation: Venenzentrum Freiburg, Deutschland.
authors.forename: K
authors.initials: K
authors.lastname: Hartmann
authors.affiliation: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin, Deutschland.
authors.forename: S
authors.initials: S
authors.lastname: Roll
mesh_terms: D000328:Adult; D017222:Angioplasty, Balloon, Laser-Assisted / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008026:Ligation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000209:etiology*; D011446:Prospective Studies; D012008:Recurrence; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000601:surgery*; D014463:Ultrasonography; D014648:Varicose Veins / Q000000981:diagnostic imaging / Q000601:surgery*