To compare the success rate and the occurrence of complications of re-crossectomy and (repeated) UGFS for the treatment of recurrence of the SSV for a period of 5 years.
ID
Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anatomical and/or hemodynamic success on ultrasound examination. Success is
defined by the absence of reflux >0.5 seconds (with or without sclerus) in the
SSV at 2 sites: the saphenopopliteal junction and halfway the calf (after 3, 12
months and 5 years).
Secondary outcome
1. Number of additional UGFS treatments after the randomized treatment.
2. Number and type of additional treatments for varicosities in study limb.
3. Patient's satisfaction about the treatment (10-points scale, from very
unsatisfied to very content) after 3 and 12 months.
4. Quality of life, measured with the SF-36 test on t=0, after 2 weeks and
after 3 months.
5. Patient's reported complications (pain, hematoma, infection, paresthesia)
and doctor's reported complications after 2 weeks (superficial and deep
thrombosis, hyperpigmentation).
Background summary
Complications of primary varicose veins have a great impact on patients* health
related quality of life, which is comparable to other common diseases, and is
associated with considerable health care costs. Treatment of varicose veins is
important in prevention of complications. Crossectomy and ultrasound guided
foam sclerotherapy (UGFS) are the common treatment modalities of insufficiency
of the SSV. Crossectomy is a relatively difficult operation and has a high
recurrence rate (50% after 5 years). Re-crossectomy of the SSV is even more
difficult because the anatomy has changed and the veins are usually tortuous.
Re-operation is again associated with a high risk of recurrence or failure.
UGFS is a swift and easy treatment whereby the SSV is punctured and injected
with foam. With this treatment there is no need of (general or spinal)
anesthesia.
Study objective
To compare the success rate and the occurrence of complications of
re-crossectomy and (repeated) UGFS for the treatment of recurrence of the SSV
for a period of 5 years.
Study design
Prospective randomized study of success and complications of re-crossectomy and
(repeated) UGFS for treatment of recurrence (after crossectomy in the past) of
the SSV.
Intervention
crossectomy vs ultrasound guided sclerofoam therapy
Study burden and risks
The treatments within the study are identical to the treatments that would be
normally given to the same patient. The study only compares the effectivity and
complications of the two regular treatments. The burden for the patient will be
two extra visits to the hospital, 15 minutes each. Also the patients will be
asked to fill in two questionairies which will take approximately 30 minutes.
Burg Jacobusplein 51
3000 CA Rotterdam
NL
Burg Jacobusplein 51
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Objective insufficiency (> 0.5 seconds on ultrasound examination) of the SSV after crossectomy (with or without stripping) with visible neovascularisation at the sapheno-popliteal junction
Exclusion criteria
thrombosis (superficial or deep) or thrombotic disease
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 | NL25689.101.08 |