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VARICO TRIAL, Prospective randomised trial to analyse short and long term results of stripping versus endovenous laser treatment of long saphenous vein incompetence under local anaesthesia.


- candidate number3101
- NTR NumberNTR1243
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mrt-2008
- Secondary IDs12256.049.07 
- Public TitleVARICO TRIAL, Prospective randomised trial to analyse short and long term results of stripping versus endovenous laser treatment of long saphenous vein incompetence under local anaesthesia.
- Scientific TitleVARICO TRIAL, Prospective randomised trial to analyse short and long term results of stripping versus endovenous laser treatment of long saphenous vein incompetence under local anaesthesia
- ACRONYMN/A
- hypothesisThe recurrence risk after endovenous laser treatment is less than after stripping of the long saphenous vein performed under local anaesthesia.
- Healt Condition(s) or Problem(s) studiedAnesthesia, Endovenous laser technique, Stripping, Great saphenous vein
- Inclusion criteria1. Long saphenous vein (LSV) incompetence (duplex: reflux > 0,5 sec. measured and seen in standing position by manual compression or valsalva manouvre)
2. Diameter of LSV equal or more than 0,3 cm and equal or less than 1,5 cm
3. Length of LSV traject more than 15 cm intrafascial
4. No earlier operations
5. Age between 18-70 years
6. CEAP classification equal or more than C2
7. Informed consent
- Exclusion criteria1. Patient does not meet the therefore mentioned inclusion criteria
2. Pregnancy
3. Immobility
4. Pathology deep venous system
5. Patients don't wish to be operated under local anaesthesia
6. Proven reaction on lidocaine
7. Contra indications to stop Clopidogrel or coumarine or that can not be stopped or temporarely replaced by fraxiparine
8. Flebitis in time of surgery
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-feb-2008
- planned closingdate25-feb-2020
- Target number of participants274
- Interventions- Stripping method
- Endovenous laser therapy
- Primary outcomePrimary endpoint is the recurrence rate of the varicose vein.
- Secondary outcomeSecondary endpoints are complicatons and quality of life.
- TimepointsRecurrence of varicose vein can be diagnosed from 6 month till several years after operations. Interim analyse will be done from 1 year till 10 years after the operation.
- 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
- PublicationsEur J Vasc Endovasc Surg. 2010 Nov;40(5):649-56.

Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.
Pronk P, Gauw SA, Mooij MC, Gaastra MT, Lawson JA, van Goethem AR, van Vlijmen-van Keulen CJ.

Flebologisch Centrum Oosterwal, Overkrocht 10, 1815 KX Alkmaar, The Netherlands. pascalpronk888@hotmail.com.
- Brief summaryEarly veins are relatively benign, but some patients will progress to develop severe and irreversible problems of chronic venous insufficiency, including venous ulcers. Surgery, by high ligation and stripping of thrunk veins, is still considered the "gold standard" for treatment of varicose veins in association with trunk incompetence.
Recently, the endovenous laser treament is introduced. The promissing treatment reports less recurrences. complications and a better quality of life. In this study we will compare the postoperative results of endovenous laser treatment with the traditional stripping procedure, performed under local anaesthesia.
- Main changes (audit trail)
- RECORD4-mrt-2008 - 16-apr-2011


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