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VARICO 2 TRIAL: Prospective randomised trial analyzing results after Radiofrequency Obliteration VNUS ClosureFAST and Endovenous Laser Ablation ELVeS Radial Fiber 1470nm using local timescent anaesthesia for great saphenous vein incompetence.


- candidate number9333
- NTR NumberNTR2854
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2011
- Secondary IDs2011/125 METC VUmc
- Public TitleVARICO 2 TRIAL: Prospective randomised trial analyzing results after Radiofrequency Obliteration VNUS ClosureFAST and Endovenous Laser Ablation ELVeS Radial Fiber 1470nm using local timescent anaesthesia for great saphenous vein incompetence.
- Scientific TitleVARICO 2 TRIAL: Prospective randomised trial analyzing results after Radiofrequency Obliteration VNUS ClosureFAST and Endovenous Laser Ablation ELVeS Radial Fiber 1470nm using local timescent anaesthesia for great saphenous vein incompetence.
- ACRONYMN/A
- hypothesisHigher occlusion rate in the EVLA group seen at 1 week postoperative. More recurrences seen in the VNUS group seen at long term. No differences in short term recovery results between both groups.
- Healt Condition(s) or Problem(s) studiedComplications, Pain, Quality of life, Relapse, Tumescent anaesthesia
- Inclusion criteria1. Incompetence of great saphenous vein, (reflux >0,5 seconds);
2. Lenght of treated vein >15 cm;
3. Diam; >0,3 cm and <1,5 cm;
4. Age >18 year;
5. No primary treatment;
6. CEAP equal or greater than 2;
7. Informed consent procedure.
- Exclusion criteria1. Primary treatment of great saphenous vein incompetence;
2. Pregnancy;
3. Immobility;
4. Pathology, not willing/able to have local tumescent anaesthesia;
5. Hypersensibility for lidocain;
6. Flebitis in time of surgery;
7. Serpentin-like veins.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-jan-2011
- planned closingdate30-jun-2016
- Target number of participants400
- Interventions1. Endovenous Laser Ablation 1470 nm RADIAL fiber;
2. VNUS ClosureFAST.
- Primary outcomeOcclusion- and recurrence rate.
- Secondary outcome1. Quality of Life;
2. Complications;
3. Pain.
- Timepoints1. 1 week occlusion;
2. Two weeks recovery;
3. Every year recurrence rate, till 5 year after the treatments.

For the measurements VAS-scores are used and questionnaires as the euroqual 5.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESBN S.A. Gauw
- CONTACT for SCIENTIFIC QUERIESDr. C.J. Vlijmen, van
- Sponsor/Initiator Ab Aquapendente Research
- Funding
(Source(s) of Monetary or Material Support)
Ab Aquapendente Research
- PublicationsN/A
- Brief summaryEarly varicose veins are relatively benign but some patients will progress to develop severe problems, including venous ulcers. Endovenous treatments like VNUS-ClosureFAST and Endovenous Laser Ablation are promising procedures for the treatment of trunk vein incompetence. Post operative these treatments give less complications and a better quality of life compared to surgery as stripping. Occlusion - and recurrences rate seen on short and long term is our main outcome parameter. We hypothesize that occlusion rate will be higher in the EVLA group and recurrence rate will be higher in de VNUS group. There will be no difference in quality of life after both treatments.
- Main changes (audit trail)
- RECORD13-apr-2011 - 18-mei-2011


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