Analysis of short and long term results of stripping and endovenous laser treatment for long saphenous vein incompetence under local anaesthesia.Endpoint is the recurrence rate of the varicose vein, secondary endpoints are pain, complications,…
ID
Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter: recurrence rate of varicose veins in the operated
area.
Secondary outcome
Secondary study parameters: pain, satisfaction, quality of life and
complications and cost-effectiveness analises.
Background summary
Varicose veins are a common problem in both men and women. The prevalence
increases with age. In almost one third of the adult population varicosity is
present. The aetiology is most due to genetic risk factors and age.
Early varicose veins are relatively benign, but some patients will progress to
develop severe and irreversible problems of chronic venous insufficiency,
including venous ulcers.
Surgery, by high ligation and stripping of trunk veins, is still considered the
'old standard' for treatment of varicose veins in association with trunk vein
incompetence. Recently, the endovenous laser treatment is introduced. This
promising treatment reports less recurrences, complications and better quality
of life.
Our institute is specialised in treating lower extremity superficial venous
insufficiency.
In this study we will compare the postoperative results of the endovenous laser
treatment with the traditional stripping procedure, performed under local
anaesthesia.
Study objective
Analysis of short and long term results of stripping and endovenous laser
treatment for long saphenous vein incompetence under local anaesthesia.
Endpoint is the recurrence rate of the varicose vein, secondary endpoints are
pain, complications, satisfaction and quality of life and profit costs
analises.
Study design
The aim of this randomized prospective intervention study is to compare two
methods of treatment (stripping versus endovenous laser treatment for long
saphenous vein incompetence) and the postoperative results during a follow up
of 10 years.
By using the ultrasound, the diagnosis insufficiency of the long saphenous vein
will be determinated. If an operation is needed the treatment options will be
discussed with the patient. The operation will be performed under local
anesthesia. Check ups will take place after 1 and 6 weeks and 6 and 12 months,
as we are used to do. More check ups will take place once a year during the
following 9 years. During the check- up we will perform an ultrasound and ask
the patient to fill out a questionnaire (EuroQuol5: quality of life and
registration of complications, last questionnaire at 6 months)
Intervention
One group of the patients with an incompetence of the long saphenous vein (LSV)
are treated with surgical ligation and stripping of the LSV. The other group
will be treated with the endovenous laser technique. Both procedures are
performed under local anaesthesia and after the operation all patients will be
treated with sclerotherapy and elastic compression bandage.
Study burden and risks
Postulation of the indication for operation, the operation and the
postoperative check-ups up to one year is what we are used to do in every
operated patient in our institute. Extra check-ups for 9 years will take place
after the first year. Ultrasound investigation (a non-invasive investigation)
and the questionnaires that have to be filled out during the first 3 check-ups
are not aggravating.
Koninginneweg 9
1217 KP Hilversum
NL
Koninginneweg 9
1217 KP Hilversum
NL
Listed location countries
Age
Inclusion criteria
Incompetence of the long saphenous vein
Exclusion criteria
pregnancy
immobile patient
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 | NL12256.094.07 |