|- candidate number||7740|
|- NTR Number||NTR2202|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-feb-2010|
|- Secondary IDs||NL30280.068.09 CCMO|
|- Public Title||‘Comparison of costs and patient reported outcomes of endovenous techniques in the treatment of incompetent saphenous veins;’
A single center, double blinded, randomized controlled trial.
|- Scientific Title||‘Comparison of costs and patient reported outcomes of endovenous techniques in the treatment of incompetent saphenous veins;’
A single center, double blinded, randomized controlled trial.|
|- Healt Condition(s) or Problem(s) studied||Varicose veins, Endovenous treatment, VNUS, Endolaser|
|- Inclusion criteria||1. Primary truncal saphenous incompetence; |
2. Normal deep venous system;
3. Reflux time > 0.5 s after distal compression in standing position (in GSV or SSV);
4. Patient should be physical able and willing to be treated with one of the two treatments;
5. Age > 18 years;
6. No sex discrimination;
7. Enough knowledge/understanding of the Dutch language;
8. Diameter > 4 mm due to the catheter used in both endovenous techniques.
|- Exclusion criteria||1. Signs of DVT- residues visible on duplex;|
2. Thrombus in vein of interest;
3. Previous GSV or SSV treatment;
5. Known malignancy;
6. Known adverse reaction for used local anaesthesia.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2010|
|- planned closingdate||1-apr-2011|
|- Target number of participants||70|
|- Interventions||Treatment of saphenous incompetence with VNUSclosureFAST system, or with the radial fiber 1470 nm endolaser.|
|- Primary outcome||1. Patient treatment satisfaction in terms of health related quality of life improvement;|
2. (Post-operative) pain scores;
3. Clinical changes (venous clinical severity scores and CEAP-classification);
4. (Serious) side effects.
|- Secondary outcome||Direct costs of both treatments.|
|- Timepoints||Start including 01-04-2010.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| C. Sobczak|
|- CONTACT for SCIENTIFIC QUERIES|| C. Sobczak|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief summary||Surgical ligation and stripping of the saphenous veins has shown extended recovery times, higher post-operative pain scores and inferior patient satisfaction. Side effects like pain, bruising and nerve damage have been reported frequently. Surgical treatment of the small saphenous veins is known of its high percentage of recurrences after treatment. |
With the advantage of minimally invasive ultra-sound guided techniques new treatment opportunities have been created to combine an optimal occlusion rate of the incompetent vein with a minimum of side effects. As mentioned in the introduction endolaser- and radiofrequency ablation have both a good comparable effectiveness and surgery more often makes place for these endovenous techniques.
It depends on the specialist and available hospital devices which technique- the radiofrequency or the lasertherapy- is chosen for the treatment of the incompetent saphnenous veins. In the Netherlands radiofrequency and endolaser are becoming increasingly popular because of the reimbursement of health care costs in the Netherlands and the high effectiveness for these techniques.
To make firm recommendations there is a need for a well designed prospective trial in which comparison of costs and patient related outcomes between laser en radiofrequency are studied.
Data derived from such a study are indispensable for the development of guidelines on the treatment of varicose vein insufficiency aimed at maximizing patient acceptability and minimizing costs. This can contribute to a standardization and guideline for the treatment of varicose veins by endovenous ablation techniques.To compare effectiveness in terms of costs and patients preference between the VNUS fast closure procedure and the radial fiber 1470 nm endolaser. These are two equally accepted and applied treatments for treatment of patients with incompetent saphenous veins (both GSV en SSV).
|- Main changes (audit trail)|
|- RECORD||8-feb-2010 - 17-feb-2010|