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Is wearing compressive stockings useful after Endovenous Laser Therapy (EVLT)?


- candidate number9047
- NTR NumberNTR2738
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jan-2011
- Secondary IDs32137 CCMO
- Public TitleIs wearing compressive stockings useful after Endovenous Laser Therapy (EVLT)?
- Scientific TitleIs wearing compressive stockings useful after Endovenous Laser Therapy (EVLT)?
- ACRONYM
- hypothesisNowadays after every venous treatment some form of compressive treatment is prescribed. Its use has been proven for surgical interventions, but is unclear for EVLT. Patients often think of wearing of these stockings as a burden.Therefore we will conduct a randomised clinical trial to define the use of wearing compressive stockings after EVLT.
- Healt Condition(s) or Problem(s) studiedEndovenous laser technique, Varicosis, Compressive stockings
- Inclusion criteriaVenous insufficiency Greater Saphenous Vein (GSV), to be treated using EVLT
- Exclusion criteria1. Chronic venous insufficiency;
2. Already wearing compressive stockings;
3. Periferal arterial disease;
4. Previous treatment GSV;
5. Age < 18 yrs;
6. Insufficient understanding dutch language.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate31-dec-2011
- Target number of participants180
- InterventionsAfter randomisation the studygroup will not be wearing compressive stockings, whereas the control group will be wearing compressive stockings for 2 weeks after the treatment.
- Primary outcomeQuality of life, as measured with AVVQ and VCCS.
- Secondary outcomePainscore and complications, measured using a visual assisted painscore and physical examination.
- TimepointsT0= Outpatient clinic visit;
T1= Treatment;
T2= 2 weeks after treatment;
T3= 4-6 weeks after treatment;
T4= 1 year after treatment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMw. Drs. A.J. Runia
- CONTACT for SCIENTIFIC QUERIESMw. Drs. A.J. Runia
- Sponsor/Initiator Sint Franciscus Gasthuis (SFG)
- Funding
(Source(s) of Monetary or Material Support)
Maatschap chirurgie SFG, Rotterdam
- PublicationsN/A
- Brief summaryVaricose veins may cause complaints of pain, tiredness of the legs, cosmetic complaints, iching or muscle cramp in calf or feet. EndoVenous Laser Therapy (EVLT) is the treatment of choice in our hospital for insufficiency of the greater saphenous vein (GSV) where thermic ablation of the vein is effectuated under local anesthesia. After the EVLT patients nowadays arre proscribed compressive stockings for a period of time, that differs in every clinic and with every clinician. However, the need to wear these compressive stockings after EVLT has never been proven. Therefore we want to conduct a prospective randomised clinical trial, at which the the study group will not be wearing compressive stockings. The primary objective of this prospective randomised clinical trial will be quality of life, as to be measured using the Dutch Translated AVVQ. Secundary objectives will be quality of life, painscore and complications, measured using the VCSS, a visual assisted painscore and physical examination. Furthermore wil will examin the effectivity of our treatment of these varicose veins using duplex-ultrasound. After power analysis we will include 300 patients. These patients will all be treated for insufficiency of the GSV. After randomisation the studygroup will not be wearing compressive stockings, whereas the control group will be wearing compressive stockings for 2 weeks after the treatment. The follow-up is going to be one year.
- Main changes (audit trail)
- RECORD31-jan-2011 - 19-feb-2011


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