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

Venous insuffiency of the lower limbs is a common medical condition and
accounts for substantial expenditure in the western world. Results from
several epidemiologic studies show that a quarter of the adult population has
insufficency of the truncal veins in the legs. Valvular incompetence of the
great and small saphenous vein is the most frequent cause of venous
insufficiency. Since the incidence increases with age in a linear manner, the
prevalence will increase in the coming years.
The treatment of superficial venous disease has undergone enormous changes
during the past decade. The introduction of minimal invasive endovenous
techniques has proven to be an effective intervention. These techniques
include echo-guided foam sclerotherapy, endovenous radiofrequency ablation
(RFA; VNUS closureFAST) and laser (EVLA), and were introduced to improve
efficiency, optimalize patient health related quality of life, enlarge patients
treatment satisfaction and reduce serious side effects, costs and postoperative
pain.
The endovenous lasertherapy (EVLA) damages the vein wall with a high
temperature produced by laser energy. Radiofrequency ablation (RFA) is also a
thermal ablation technique, based on radiofrequency energy.
Compared to the *gold standard*, the surgical ligation and stripping procedure,
the recovery time of patients after endovenous treatment is faster and there is
less postoperative pain. Studies comparing EVLT and RFA with surgical stripping
suggested that they were equally effective (comparable recurrence rates), but
patient reported outcomes were in favour of the minimal invasive endovenous
techniques.
In this study we will compare the thermal endovenous techniques , endolaser
(EVLT) versus radiofrequency ablation (RFA). Both techniques have proven to be
safe and are comparable effective.
Our primary objective is the hypothesis that both techniques have the same
patient satisfaction, counted in terms of quality of life improvement, post
operative pain, side effects and clinical changes. We want to refute the
supposition that the VNUS closureFAST technique accounts for higher patient
satisfaction as concluded from the RECOVERY study in which RFA
(VENUSclosureFAST) is compared with the 980 nm endolaser. Recent research has
shown that the new radial fiber 1470 nm endolaser, compared to historical
endolaser control (980 nm, 80 J/cm, 12 W) minimizes post-operative pain and
ecchymosis. This implies that vein-wall perforations (causing these side
effects) are minimized with this system. This can be explained by the fact
that this water specific laser wavelength (WSLW) is preferentially absorbed by
water 40 times more than a 980-nm wavelength. It is hypothesized that water
specific laser wavelengths would more readily target the vein wall and more
readily ablate veins at lower energy densities, resulting in fewer side
effects. 2 comparative studies have demonstrated that patients treated with
WSLW reported less post-operative pain, used less painkillers, and were less
likely to have ecchymosis.

We want to investigate the patient satisfaction after both treatments and
differentiation in direct costs between the radiofrequency ablation (by VNUS
closureFAST) and treatment with the radial fiber 1470 nm endolaser.
We want to compare both treatments in patients with incompetent saphenous veins
(great saphenous vein (GSV) and the small saphenous vein (SSV), There is no
prospective randomized trial known comparing the VNUS closureFAST (RFA) with
the radial fiber 1470 nm endolaser (EVLT). Noticing both techniques are
comparable effective, lower costs together with greater patient satisfaction
will lead to firm recommendations. A comparison of costs and patient reported
outcomes is needed to enable us to make these firm recommendations. In our
prospective trial patient reported outcome is defined as patient satisfaction,
in terms of quality of life improvement, postoperative pain, side events and
clinical changes. Eventually we want to investigate if there is a correlation
between the difference in costs and patient satisfaction.

The study will be a single-center, double blinded, randomized controlled trial
wherein patients with a primary incompetent truncal saphenous vein are randomly
assigned either to 1) laser (EVLT) or 2) radiofrequent ablation (RF). To
maintain the double blinded nature of the study, the actual treatment procedure
is not discussed with the participants. The study population will consist of
patients with an incompetent truncal saphenous vein (GSV or SSV) and will be
recruited from visits to our outpatient*s clinic of the department of
Dermatology of the University Hospital Maastricht (MUMC+). There will be a
follow up of 4 weeks after treatment. We believe that most postprocedural
effects resolve after one month. Follow up visits will be planned at week 1
week and 1 month. When we see exceptional abnormalities at 1 month we will
enlarge the follow up for those patients till 6 weeks (regular control visit
for patients treated with VNUSclosureFAST or endolaser). The independent
(blinded) clinician, who is present at baseline and at each follow up visit,
evaluates the post-procedural effects (occlusion, venous clinical severity
score, CEAP, side effects) and does not know in which therapy-arm the patient
is treated. This is possible because of the same post-procedural marks.
Questionnaires will be filled in at baseline and 1, 2, 3 and 4 weeks after
treatment.
Clinical severity and CEAP-scores will be scaled at baseline and 4 weeks after
treatment by the same independent blinded clinician, not knowing in which
treatment arm the patient is treated.
Control Duplex will take place 1 week and 4 weeks after treatment (occlusion,
flow, reflux) and will be performed by the same independant blinded clinician.
VAS-painscores and the 'pain questionnaire' will be collected 48 hours after
treatment and after 1, 2, 3 and 4 weeks.
See flow chart (protocol page 9)

Treatment of saphenous incompetence with either 1. VNUSclosureFAST-method or 2.
radial fiber 1470 nm endolaser

Risks of the research are the normal risks which can possible occur from the
treatment with radiofrequent ablation or endolaser therapy.
Ecchymosis, pain, induration, skin burns, dysesthesia, superficial
thrombophlebitis, and hematoma are classified as minor complications. Deep vein
thrombosis and nerve injury are classified as major complications.
After one week there is a regular follow up visit and ultrasound control of the
junction is performed to exclude thrombosis. In case of complains patients can
be seen earlier in our outpatient clinic and a ultrasound will be made.
After the radiofrequent ablation or endolaser technique patients can feel some
pain for some days, a recipe for painkillers is prescribed.
There is an independent specialist for the patients where they can go with
questions and complaints about the research.