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Cryo strip versus classic strip of the great saphenous vein.


- candidate number2506
- NTR NumberNTR926
- ISRCTNISRCTN61851091
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR10-mrt-2007
- Secondary IDs 
- Public TitleCryo strip versus classic strip of the great saphenous vein.
- Scientific TitleCryo strip versus classic strip of the great saphenous vein.
- ACRONYMN/A
- hypothesisRecurrence rate of cryo strip is the same as classic strip of the great saphenous vein.
- Healt Condition(s) or Problem(s) studiedGreat saphenous vein, Great saphenous vein, Venous, Venous surgery, Cryo strip, Classic strip
- Inclusion criteria1. Patients with primary varicosis and incompetence of the great saphenous vein and saphenofemoral junction (confirmed by duplex). Only patients with C2, C3, C4 varicosis (CEAP-classification).
- Exclusion criteria1. C5, C6 varicosis;
2. Extreme adipositas (BMI>40);
3. Deep venous occlusion;
4. Incompetence of the small saphenous vein;
5. Aarterial occlusive disease of the legs;
6. Inability to understand the Dutch language;
7. Recurrence of varicosis of the leg.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2002
- planned closingdate1-okt-2006
- Target number of participants520
- InterventionsCryo strip of the great saphenous vein versus classic strip of the great saphnous vein.
- Primary outcomeRecurrence, confirmed by venous duplex.
- Secondary outcome1. Operation time;
2. Neurological damage after surgery;
3. Quality of life.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES T.M.A.L. Klem
- CONTACT for SCIENTIFIC QUERIES T.M.A.L. Klem
- Sponsor/Initiator Sint Franciscus Gasthuis (SFG) , Albert Schweitzer Ziekenhuis , Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sint Franciscus Gasthuis (SFG), Rotterdam, Albert Schweitzer Ziekenhuis, Dordrecht
- PublicationsN/A
- Brief summaryIn this trial we compare cryo strip versus classic strip of the great saphenous vein. Primary outcome is recurrence rate, conformed by venous duplex.
- Main changes (audit trail)
- RECORD10-mrt-2007 - 9-sep-2009


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