The main objective is to determine whether the post-operative application of elastic stockings after varicose vein surgery is useful to reduce post-operative pain. Secondly we want to determine whether there is a difference in physical functioning…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint are the pain scores.
Secondary outcome
Secondly we will assess the number of complications, functioning scores, number
of re-interventions, amount of analgesics consumption, time before returning to
work and leg edema.
Background summary
The standard surgical treatment for varicose veins is stripping of the greater
saphenous vein. Post-operatively, patients usually receive compression therapy
with elastic stockings. However, no evidence is available to support this
routine and frequently the patients experience discomfort from the use of these
stockings. Our hypothesis is that routine application of elastic stockings
after varicose vein surgery is not beneficial with regard to pain- and physical
functioning scores, complications, edema formation, time before returning to
work, analgesics consumption and number of re-interventions.
Study objective
The main objective is to determine whether the post-operative application of
elastic stockings after varicose vein surgery is useful to reduce
post-operative pain. Secondly we want to determine whether there is a
difference in physical functioning scores, complications, leg edema, time
before returning to work analgesics consumption and number of re-interventions
between wearing and not wearing elastic stockings post-operatively.
Study design
Prospective randomised trial. Patients will be randomised to either a group who
wears elastic stockings 2 weeks post-operatively or a group who does not wear
elastic stockings post-operatively after varicose vein surgery.
Intervention
One group wears elastic stockings (class II) for two weeks post-operatively and
one group does not wear elastic stockings.
Study burden and risks
The burden to the patients is that they have to visite the hospital one extra
time beside the usual check-ups. The filling out of the questionnaires takes 15
minutes per visit. The patients* leg circumference of both legs will be
measured at 3 points each visit on a non-invasive way. Patients are asked to
fill out a VAS-score each day in the first day post-operatively and in the
following 5 weeks weekly. Further more patients will be asked to register the
amount of analgesics consumed at home in a diary during the 6 weeks period
post-operatively.
The risk of the study is that patients not wearing stockings experience
significantly more complications, pain or other discomfort. An
interim-analysis will be carried out to prevent disadvantages to one of the
study groups.
Dr. H van der Hoffplein 1
6162 BG Sittard-Geleen
Nederland
Dr. H van der Hoffplein 1
6162 BG Sittard-Geleen
Nederland
Listed location countries
Age
Inclusion criteria
- Age between 18 and 65 years
- Duplex-proven varicose veins with insufficient sapheno-femoral crosse
- CEAP-classification: C1-4EpAs,pPr
- Informed consent
Exclusion criteria
- Pregnancy
- Refusal of informed consent
- Deep venous thrombosis in medical history
- Previous surgery to vascular structures in lower extremities
- Secondary varicose veins
- Ulcerative lesions on lower extremities
- Contra-indication for use of elastic stockings
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 | NL26229.096.08 |