Surgery or Noninvasive Therapy for Varicose Veins (Magna)
Recruitment status was: Recruiting
|Varicose Vein||Procedure: crossectomy and short stripping Procedure: ultrasound guided sclerotherapy with foam Procedure: endovenous laser therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy|
- anatomical success rate (absence or obliteration of GSV on US examination) [ Time Frame: 3 months, 1 and 5 years ]
- treatment related adverse events and complications [ Time Frame: 3 months, 1 and 5 years ]
- patient reported outcomes (HRQOL and treatment satisfaction) [ Time Frame: 3 months, 1 and 5 years ]
- cost effectiveness analysis [ Time Frame: 3 months, 1 and 5 years ]
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Surgery: crossectomy plus short stripping
Procedure: crossectomy and short stripping
under spinal or complete anaesthesia
Active Comparator: 2
ultrasound guided sclerotherapy with foam (3% polidocanol)
Procedure: ultrasound guided sclerotherapy with foam
1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
Active Comparator: 3
Endovenous laser therapy (940 nm, about 70 J/cm)
Procedure: endovenous laser therapy
940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.
Hide Detailed Description
- Ultrasound confirmed GSV insufficiency (reflux time >0.5 second and vein diameter ≥0.5 cm)
- non-treated GSV varicosis
- CEAP -classification > C2 and As2
- >18 years old
- Informed consent.
- Acute venous thrombosis / phlebitis
- Absence of deep venous system
- Vascular syndromes
- Post-thrombotic syndrome of occlusive type
- Contra-indications for surgery
- use of anticoagulants
1. anatomical success using US (absence of GSV or flow) (at 3 months, 1 and 5 year)
- treatment induced adverse events and complications (after 3 months)
- patient reported outcomes (HRQOL and treatment satisfaction)(after 3 months)
- cost effectiveness analyses (after 1 and 5 years)
Included patients: total of 240 (80 per arm)
Study start: May 2007 (recruitment ongoing) Study completion: May 2011
Follow up after 3 months, 1, 2, 3, 4 and 5 years
Location: department of dermatology, Erasmus MC, Rotterdam, The Netherlands
Principle investigators: M. Kockaert, T. Nijsten & M. Neumann
Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. Epub 2007 Jun 27.
Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. Role of endovenous laser treatment in the management of chronic venous insufficiency. Ann Vasc Surg. 2007 Sep;21(5):551-5.
Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg. 2005 Oct;92(10):1189-94.
Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C.Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007 Aug;94(8):925-36.
Subramonia S, Lees TA.The treatment of varicose veins.Ann R Coll Surg Engl. 2007 Mar;89(2):96-100.
Bohler K. Varicose veins: disfigurement or disease? Herz. 2007 Feb;32(1):18-25.
Bamigboye AA, Smyth R. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001066.
van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. New endovenous therapies of truncal varicosities are more effective than surgical stripping and sclerotherapy: meta-analysis and meta-regression. Lancet, Submitted
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529672
|Contact: Michael Kockaert, MD||31 10 4634580||M.KOCKAERT@ERASMUSMC.NL|
|Contact: Tamar Nijsten, MD, PhD||31 10 firstname.lastname@example.org|
|Erasmus MC dermatology||Recruiting|
|Rotterdam, Netherlands, 3000 CA|
|Contact: Michael Kockaert, MD 31 10 4634580 email@example.com|
|Contact: Tamar Nijsten, MD, PhD 31 10 4631019 firstname.lastname@example.org|
|Sub-Investigator: Prof. sambeek, MD, PhD|
|Principal Investigator:||Martino Neumann, MD, PhD||Erasmus MC|