Efficacy and Safety of Great Saphenous Vein Sclerotherapy Using Standardised Polidocanol Foam (ESAF): A Randomised Controlled Multicentre Clinical Trial

European Journal of Vascular and Endovascular Surgery

Volumn 35, Issue 2, 2008, Pages 238-245

  Rabe, E ^a   Otto, J ^b   Schliephake, D ^b   Pannier, F ^a  

^a UNIVERSITY OF BONN   (Germany)

^b Chemische Fabrik Kreussler and Co GmbH   (Germany)

Author keywords

Foam; Great saphenous vein; Polidocanol; RCT; Sclerotherapy

Indexed keywords

POLIDOCANOL;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEMORAL VEIN; FOAM; GREAT BLOOD VESSEL; HEMATOMA; HUMAN; HYPERPIGMENTATION; HYPERTENSION; INTRAVASCULAR ULTRASOUND; LIQUID; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PAIN; PARESTHESIA; PATIENT SATISFACTION; PHLEBITIS; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SAPHENOUS VEIN; SCLEROTHERAPY; SEBORRHEIC DERMATITIS; SIDE EFFECT; SKIN INDURATION; TASTE DISORDER; THROMBOPHLEBITIS; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; URTICARIA; VARICOSIS; VEIN DIAMETER; VEIN DISEASE; VEIN INSUFFICIENCY; VEIN OCCLUSION; VENOUS PRESSURE;

ADULT; AGED; FEMALE; GERMANY; HUMANS; MALE; MIDDLE AGED; PATIENT SATISFACTION; POLYETHYLENE GLYCOLS; PROSPECTIVE STUDIES; QUESTIONNAIRES; SAPHENOUS VEIN; SCLEROSING SOLUTIONS; SCLEROTHERAPY; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER, DUPLEX; VARICOSE VEINS; VENOUS INSUFFICIENCY;

EID: 38549105610     PISSN: 10785884     EISSN: 15322165     Source Type: Journal    
DOI: 10.1016/j.ejvs.2007.09.006     Document Type: Article

References (29)

1. Merchant R.F., and Pichot O. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 42 3 (2005) 502-509
2. Hinchliffe R.J., Ubhi J., Beech A., Ellison J., and Braithwaite B.D. A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg 31 2 (2006) 212-218
3. Lurie F., Creton D., Eklof B., Kabnick L.S., Kistner R.L., Pichot O., et al. Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up. Eur J Vasc Endovasc Surg 29 1 (2005) 67-73
4. Nicolini P., and Closure Group. Treatment of primary varicose veins by endovenous obliteration with the VNUS closure system: results of a prospective multicentre study. Eur J Vasc Endovasc Surg 29 4 (2005) 433-439
5. Perälä J., Rautio T., Biancari F., Ohtonen P., Wiik H., Heikkinen T., et al. Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study. Ann Vasc Surg 19 5 (2005) 669-672
6. Min R.J., Khilnani N., and Zimmet S.E. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol 14 8 (2003) 991-996
7. Pannier F., and Rabe E. Endovenöse Lasertherapie der insuffizienten Vena saphena parva mit dem 980-nm-Diodenlaser. Phlebologie 35 6 (2006) 294-299
8. Proebstle T.M., Moehler T., Gul D., and Herdemann S. Endovenous treatment of the great saphenous vein using a 1,320 nm Nd: YAG laser causes fewer side effects than using a 940 nm diode laser. Dermatol Surg 31 12 (2005) 1678-1683
9. Kanter A. Clinical determinants of ultrasound-guided sclerotherapy outcome - Part I: the effect of age, gender, and vein size. Dermatol Surg 24 1 (1998) 131-135
10. Schadeck M. Sclérose èchoguidée de la grande saphène. Phlébologie 53 2 (2000) 169-172
11. Schultz-Ehrenburg U., and Tourbier H. Dopplerkontrollierte Verödungsbehandlung der Vena saphena magna. Langzeitergebnisse und prognostische Gruppen. Phlebol Proktol 13 2 (1984) 117-122
12. Barrett J.M., Allen B., Ockelford A., and Goldman M.P. Microfoam ultrasound-guided sclerotherapy treatment for varicose veins in a subgroup with diameters at the junction of 10mm or greater compared with a subgroup of less than 10 mm. Dermatol Surg 30 (2004) 1386-1390
13. Demagny A. Étude comparative de l'efficacité d'un produit sclérosant sous ses formes liquide ou mousse dans la sclérose échoguidée des crosses de grandes et petites veines saphénes. Phlébologie 55 2 (2002) 133-137
14. Milleret R., and Garandeau C. Sclérose des grandes veines saphénes à la mousse délivrée par cathéter écho-guidé sur veine vide: alpha-technique - Bilan des 1.000 treatments. Phlébologie 59 1 (2006) 53-58
15. Cabrera J., Cabrera Jr. J., and Garcia-Olmedo A. Treatment of varicose long saphenous veins with sclerosant in microfoam form: long-term outcomes. Phlebology 15 (2000) 19-23
16. Darke S.G., and Baker S.J. Ultrasound-guided foam sclerotherapy for the treatment of varicose veins. Br J Surg 93 8 (2006) 969-974
17. Wildenhues B. Endovenöse kathetergestützte Schaumsklerosierung. Phlebologie 34 (2005) 165-170
18. Coleridge Smith P. Chronic venous disease treated by ultrasound guided foam sclerotherapy. Eur J Vasc Endovasc Surg 32 5 (2006) 577-583
19. Myers K.A., Jolley D., Clough A., and Kirwan J. Outcome of ultrasound-guided sclerotherapy for varicose veins: medium-term results assessed by ultrasound surveillance. Eur J Vasc Endovasc Surg 33 1 (2007) 116-121
20. Sadoun S., Benigni J.P., and Sica M. Étude prospective de l'efficacité de la mousse de sclérosant dans le traitement des varices tronculaires des membres inférieurs. Phlébologie 55 3 (2002) 259-262
21. Ceulen R.P.M., Bullens-Goessens Y.I.J.M., Pi-van de Venne S.J.A., Nelemans P.J., Veraart J.C.J.M., and Sommer A. Outcomes and side effects of duplex-guided sclerotherapy in the treatment of great saphenous veins with 1% versus 3% Polidocanol foam: results of a randomized controlled trial with 1-year follow-up. Dermatol Surg 33 3 (2007) 276-281
22. Hamel-Desnos C., Allaert F.A., Benigni J.P., Boitelle G., Chleir F., Ouvry P., et al. Étude 3/1. Mousse de Polidocanol 3% versus 1% dans la grande veine saphéne: premiers résultats. Phlébologie 58 2 (2005) 165-173
23. Hamel-Desnos C., Desnos P., Wollmann J.-C., Ouvry P., Mako S., and Allaert F.A. Evaluation of the efficacy of Polidocanol in the form of foam compared with liquid form in sclerotherapy of the long saphenous vein: initial results. Dermatol Surg 29 12 (2003) 1170-1175
24. ® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 21 4 (2006) 180-190
25. Yamaki T., Nozaki M., and Iwasaka S. Comparative study of duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency. Dermatol Surg 30 (2004) 718-722
26. Breu F.X., and Guggenbichler S. European consensus meeting on foam sclerotherapy [April, 4-6, 2003, Tegernsee, Germany]. Dermatol Surg 30 (2004) 709-717
27. Breu FX, Guggenbichler S, Wollmann J-C. 2nd European consensus meeting on foam sclerotherapy, [April 28-30, 2006, Tegernsee, Germany]. VASA 2008;37, (Suppl.) in press.
28. Stücker M., Reich S., Robak-Pawelczyk B., Moll C., Rudolph T., Altmeyer P.J., et al. Changes in venous refilling time from childhood to adulthood in subjects with apparently normal veins. J Vasc Surg 41 2 (2005) 296-302
29. Guex J.-J., Allaert F.-A., and Gillet J.-L. Immediate and midterm complications of sclerotherapy: report of a prospective multicenter registry of 12,173 sclerotherapy sessions. Dermatol Surg 31 2 (2005) 123-128