|- candidate number||4583|
|- NTR Number||NTR1554|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2008|
|- Secondary IDs||2008/11 TWOR|
|- Public Title||VESPA Trial: Endovenous laser treatment versus crossectomy of the small saphenous vein.|
|- Scientific Title||VESPA Trial: Endovenous laser treatment versus crossectomy of the small saphenous vein.|
|- hypothesis||Endoveneus laser treatment op the small saphenous vein is compareble to crossectomy with regard to recurrence and therapy failure. |
|- Healt Condition(s) or Problem(s) studied||Endovenous laser technique, Small saphenous vein|
|- Inclusion criteria||1. Insufficiency of the small saphenous vein
CEAP 2 to 6 |
2. Age > 18 years old
3. Comprehension of the dutch language
4. Treatment of a least 10 cm
5. Informed consent
|- Exclusion criteria||1. Diameter less than 2 mm|
2. Simultaneous insufficiency of the large saphenous vein
3. Arterial insufficiency
5. Recurrent insufficiency of the small saphenous vein
6. Spiral shape of the small saphenous vein
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate||1-nov-2010|
|- Target number of participants||180|
|- Interventions||Endovenous laser treatment (EVLT)|
Ligation of saphenopopliteal junction
|- Primary outcome||- Insufficiency after 6 weeks (therapyfailure)|
- Insufficiency after 1 year (recurrence)
|- Secondary outcome||- Quality of life|
- Cosmetic results
- Duration of treatment
- Resumption of work.
|- Timepoints||Questionnaires preoperatively and at 1, 2, 6 and 12 weeks and 12 months.|
Duplex at 6 weeks and 12 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.C. Ham, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.C. Ham, van der|
|- Sponsor/Initiator ||Sint Franciscus Gasthuis (SFG) |
(Source(s) of Monetary or Material Support)
|- Brief summary||Venous insufficiency has a high incidence worldwide. It is seen in 5-15% of all men en 15-30% of all women in western countries, varying from cosmetic complaints to chronic venous insuffiency and ulcers. |
The prevalence of insufficiency of the small saphenous vein (SSV) is 10-18%. In the early twentieth century the surgical procedure of choice for insufficiency of the great saphenous vein (GSV) was the saphenofemoral ligation and GSV stripping.
Since stripping of the SSV resulted in a large number of nerve damages of the sural nerve, the method was adjusted to the saphenopopliteal ligation. The percentage of therapy failure (persistent insufficiency of the SSV perioperatively) is 25%. Reflux at one year was seen in 52%.
The number of therapy failure is explained by the variable anatomy of the SSV and its junction.
Endovenous laser treatment (EVLT) is a minimal invasive, percutaneous, endovenous technique causing heat mediated steam bubbles resulting in endothelial damage and occlusion of the venous segment. EVLT is a widely used technique for treatment of insufficiency of the GSV. The use of EVLT for treatment of the insufficient of the SSV has not been investigated earlier by a randomized trial.
Due to the fact that the SSV is cannulated under ultrasound guidance, it is certain the correct vein is being treated.
This may result in a reduction of therapy failures and long term insufficiency.
|- Main changes (audit trail)|
|- RECORD||24-nov-2008 - 6-dec-2008|