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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR926 |
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Date of registration:
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10/03/2007 |
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Primary sponsor: |
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Public title:
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Cryo strip versus classic strip of the great saphenous vein.
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Scientific title:
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Cryo strip versus classic strip of the great saphenous vein. - N/A |
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Date of first enrolment:
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1/8/2002 |
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Target sample size:
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520 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=926 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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T.M.A.L.
Klem |
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Address:
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, Berglustlaan 44a
3054BJ
Rotterdam
The Netherlands |
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Telephone:
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t.klem@wxs.nl |
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Email:
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Affiliation:
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Name:
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T.M.A.L.
Klem |
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Address:
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, Berglustlaan 44a
3054BJ
Rotterdam
The Netherlands |
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Telephone:
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t.klem@wxs.nl |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Great saphenous vein, Great saphenous vein, Venous, Venous surgery, Cryo strip, Classic strip
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Intervention(s)
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Cryo strip of the great saphenous vein versus classic strip of the great saphnous vein.
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Primary Outcome(s)
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Recurrence, confirmed by venous duplex.
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Secondary Outcome(s)
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1. Operation time;
2. Neurological damage after surgery;
3. Quality of life.
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Secondary ID(s)
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ISRCTN61851091
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Source(s) of Monetary Support
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Erasmus Medical Center, Sint Franciscus Gasthuis (SFG), Rotterdam, Albert Schweitzer Ziekenhuis, Dordrecht
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