A randomized controlled multicenter trial comparing modern great saphenous vein stripping with crossectomy, with modern great saphenous vein stripping without crossectomy and radiofrequency ablation for primary great saphenous vein incompetence (STRIP trial).

Chronic venous insufficiency (CVI) of the lower extremities is a common
disorder and occurs in 15% of men and 35% of women (1-3 Callam, Evans,
Margolis). The effect of venous insufficiency on quality of life is substantial
and comparable to chronic diseases such as arthritis, diabetes and
cardiovascular diseases (4 Andreozzi). The venous ulcer of the lower
extremities has a prevelence of 1% (5 Nelzen). The medical costs of CVI are
high. Almost 2% of England's medical costs are due to CVI. The signs and
symptoms of venous disease cause a decline in patients quality of life and
account for a high level of absenteeism. Recently it was shown that in standing
professions venous symptoms occur in more than 80% of workers. In 7% of the
cases this led to absenteeism (6 Krijnen). The gold standard for treatment of
CVI of the greater saphenous vein (GSV) is the so-called stripping of the
veins (7 Bos). In recent years, however, new techniques are developed and
existing techniques have been further developed in the treatment of CVI of the
GSV. The preferred treatment of CVI of the GSV is open for discussion ever
since.

To date, all studies evaluating minimally invasive interventions for treatment
of venous insufficiency of the GSV have been comparing the techniques to the
traditional method of stripping (under spinal or general anesthesia, without
using duplex imaging, with a success rate of 70-78% after 1 -3 Years) (7 Bos).
When the stripping is preformed by means of duplex imaging and local, tumescent
anesthesia, a significantly higher success rate of 90-98% is achieved after
6-12 months (15 Rasmussen). The available studies of the modern stripping and
minimally invasive techniques for the treatment of CVI of the VSM are small.
Sufficient long follow-up to illustrate superiority of one of the techniques is
lacking. Also, most techniques are evaluated only by clinical recurrence
measured with duplex echography and rarely by means of changes in patients
quality of life. Until now, it is unclear which is the most succesful
intervention in treating venous insufficiency of the GSV. This research will
answer this question by comparing head to head two of the most widely used
modern techniques in a prospective randomized study.

Prospective, randomized non-blinded, multicenter intervention study in which
three are already widely used techniques (modern stripping with crossectomy,
modern stripping without crossectomy and radiofrequency ablation) are compared
in terms of recurrence, quality of life and cost effectiveness for two years.

Patients will be enrolled in the outpatient clinic for vascular surgery.
Participating patients diagnosed with venous insuffiency of the GSV according
to the CEAP classification (appendix protocol) will be randomised in one of
three intervention groups (modern stripping with crossectomy, modern stripping
without crossectomy and radiofrequency ablation). Modern stripping is preformed
under local, tumescent anesthesia. The saphenofemoral junction will be searched
by duplex, so the incision and dissection to a minimum. The GSV will be
approched and stripped via a small incision in the groin. By using modern
stripping equipment, a second incision at knee level is abbandoned. The
optional crossectomy will be standardized. The third minimally invasive
intervention will be conducted with the VNUS ClosureFAST* Catheter without an
incision in the groin. The VNUS ClosureFAST* catheter for the treatment of
venous reflux delivers radiofrequency energy to a heating element to heat and
contract the collagen within the vein walls and cause the shrinkage and
collapse of the vessel.

The research will have little effect on the participants. Patients will recieve
one of two already wideley used treatments for treating venous insufficiency of
the GSV. After the intervention patients will enter a non-invasive follow-up
consisting of duplex examinations and completing questionnaires at fixed
intervals.