| - candidate number | 2506 |
| - NTR Number | NTR926 |
| - ISRCTN | ISRCTN61851091 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 10-mrt-2007 |
| - Secondary IDs | |
| - Public Title | Cryo strip versus classic strip of the great saphenous vein. |
| - Scientific Title | Cryo strip versus classic strip of the great saphenous vein. |
| - ACRONYM | N/A |
| - hypothesis | Recurrence rate of cryo strip is the same as classic strip of the great saphenous vein. |
| - Healt Condition(s) or Problem(s) studied | Great saphenous vein, Great saphenous vein, Venous, Venous surgery, Cryo strip, Classic strip |
| - Inclusion criteria | 1. 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 criteria | 1. 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 received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-aug-2002 |
| - planned closingdate | 1-okt-2006 |
| - Target number of participants | 520 |
| - Interventions | Cryo strip of the great saphenous vein versus classic strip of the great saphnous vein. |
| - Primary outcome | Recurrence, confirmed by venous duplex. |
| - Secondary outcome | 1. Operation time; 2. Neurological damage after surgery; 3. Quality of life. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: 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 |
| - Publications | N/A |
| - Brief summary | In 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) | |
| - RECORD | 10-mrt-2007 - 9-sep-2009 |
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