Study on the effect on the postoperative comfort of compressionbandage compared to a traditional compression stocking after endovenous Laser Therapy (EVLT) of the long saphenous veins.
ID
Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in comfort after endovenous laser therapy of the long saphenous vein
between compressionbandage and the traditional compression stocking.
Secondary outcome
Painscore after endovenous laser therapy (EVLT)
Occlusionratio on venous duplex of the long saphenous vein after endovenous
vein laser therapy (EVLT)
Background summary
Varicose veins is one of the most frequent vascular disease in humans. It is a
chronic progressie disaese which has a significant negative effect on the
quality of life. The treatment of varicose veins plays an important clinical
and economic role within general healthcare. Operative treatment of varicose
veins has a proven positive effect on qulity of life.
Also new treatment modalities such as Radiofrequency Ablation and Endovenous
Laser therapy (EVLT) result in less postoperative morbidity and shorter time to
recover because the Long Saphenous Vein(LSV) is not removed but destroyed from
within with an energy probe. To optain an optimal effect after EVLT from the
long saphenous vein compression from outside is thought to be necessary to
optain the walls of the veins to seal. Most guidelines recomment 5-10 days
postoperative compression after EVLT.
Recently a new compressionbandage came on the market which gives the same
amount of compression as the conventional compressionstocking for the period of
one week. This compressionbandage is less expensive, directly available and
more easy to use compared to the traditional compressionstocking. Since the
treatment of varicose veins plays an important role in national healthcare and
its costs we are going to investigate the effects of wearing the compreession
stocking and the compressionbandage on quality of life and postoperative
comfort after EVLT of the Long Saphenous Vein assumed that the effect on
fibrosis in the treated areas of the Long saphenous Vein are equal.
Comfort and Quality of life will be measured with the Aberdeen Varicose Vein
Severity Score (AVVSS) and the Short Form 36 (SF-36).
Study objective
Study on the effect on the postoperative comfort of compressionbandage compared
to a traditional compression stocking after endovenous Laser Therapy (EVLT) of
the long saphenous veins.
Study design
Prospective randomised trial
Intervention
Dual layer compression bandage after EVLT of the GSV
Study burden and risks
Patients will be asked to fill out two short questionnaires which takes
aproximately 5 minutes in total to fill them in.
In total the patients will be asked to fill in forms 4 times and in total it
will take 20 minutes.
Postoperative patients will be asked to visit the outpatient clinic 3 times,
after 5-7 days, 6 weeks and 3 months.
The follow-up after 5-7 days and after 6 weeks (including duples scanning) are
regular appointments. De follow-up after 3 months is an additional appointment.
Boerhaavelaan 22
Haarlem 2035 RC
NL
Boerhaavelaan 22
Haarlem 2035 RC
NL
Listed location countries
Age
Inclusion criteria
ASA 1-2
> 18 years
C2-C4 varicose veins (CEAP-classification)
Competent to act for oneself
Exclusion criteria
ASA 3 and more
< 18 years
>C4 Varices (CEAP classification)
oral anticoagulant use
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 | NL27724.094.11 |