|- candidate number||12170|
|- NTR Number||NTR3376|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mrt-2012|
|- Secondary IDs||11-T-34 METC|
|- Public Title||A randomized controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence.|
|- Scientific Title||A randomized controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence.|
|- hypothesis||The experimental treatment of 4hours TED stocking has comparable outcome as the control treatment of 72hours TED stockings.|
|- Healt Condition(s) or Problem(s) studied||Radiofrequency ablation, Compression therapy, VNUS|
|- Inclusion criteria||1. Patients with primary varicosity of the GSV, between age 18-80 year (C2 – C4 according to CEAP classification);|
2. Unilateral radiofrequency ablation.
|- Exclusion criteria||1. Ulcus cruris (C6 according to CEAP classification);|
2. Healed ulcus cruris (C5 according to CEAP classification);
3. Non-compliance to wearing pressure bandage;
4. Bilateral radiofrequency ablation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||3-okt-2011|
|- planned closingdate||1-jul-2012|
|- Target number of participants||100|
|- Interventions||1. Class II TED stocking for 4 hours (intervention group);|
2. Class II TED stocking for 72 hours (control group).
|- Primary outcome||Edema of the operated leg.|
|- Secondary outcome||1. Post-operative pain;|
2. Postoperative complications;
3. Time to full recovery.
1. The patient will recieve information about the study one to several weeks before the treatment will take place;
2. On the day of the VNUS, the patient will be included combined with the first measurements.
1. 3 days;
2. 14 days.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S.A.M. Troquay|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.G. Krasznai|
|- Sponsor/Initiator ||Atrium Medisch Centrum Parkstad|
(Source(s) of Monetary or Material Support)
|Atrium Medisch Centrum Parkstad |
|- Brief summary||In developed countries lower extremity venous insufficiency affects up to 15% of men and 35% of women. Radiofrequency ablation is an accepted treatment for patients with primary incompetence of the GSV and can be performed in an outpatient setting. The after-treatment in the Atrium MC Parkstad consists out of wearing personally measured class II TED stocking for 3 days. From our own observations and patient experiences, we know patients are restrained from mobilizing by the TED stocking and thus show passive behavior. This has a negative influence on the recovery.
In this study we aim to include 100 patients who will undergo unilateral radiofrequency ablation of the GSV. We will randomise 50 patients to the control group (class II TED stocking during 72 hours) and 50 patients to the intervention group (class II TED stocking during 4 hours).
Outcomes of this study are leg edema, post-operative pain, the existence of complications and days to full recovery. |
|- Main changes (audit trail)|
|- RECORD||30-mrt-2012 - 10-jun-2012|