This randomized trial will compare EVLT with saphenopopliteal ligation with regard to therapy failure (a) and recurrence (b). a. Insufficiency of the SSV determined by ultrasound 6 weeks post-treatment is regarded as a therapy failure. b.…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Insufficiency after 6 weeks (therapyfailure).
Insufficiency after 1 year (recurrence)
Secondary outcome
Quality of life, morbidity, cosmetic results, duration of treatment, resumption
of work.
Background 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.
Study objective
This randomized trial will compare EVLT with saphenopopliteal ligation with
regard to therapy failure (a) and recurrence (b).
a. Insufficiency of the SSV determined by ultrasound 6 weeks post-treatment is
regarded as a therapy failure.
b. Determination of insufficiency of the SSV using ultrasound after one year.
Study design
randomized multi-center trial, non blinded
Intervention
Ligation of saphenopopliteal junction versus EVLT.
Study burden and risks
The saphenopopliteal ligation is performed under spinal anaesthesia, the ELVT
is performed under local anaesthesia.
Kleiweg 500
3045 PM Rotterdam
NL
Kleiweg 500
3045 PM Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Insufficiency of the saphenopopliteal junction.
Exclusion criteria
Diameter of the small saphenous vein less than 2 mm.
Occlusion of the deep venous system
tortuous small saphenous vein
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22668.101.08 |