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ISRCTN
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ISRCTN18322872
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ClinicalTrials.gov identifier
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Public title
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To evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping
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Scientific title
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A prospective, Randomised, two-centre study to evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping
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Acronym
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RELACS
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Serial number at source
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RELACS v1.7 (10.09.2004)
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Study hypothesis
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Clinical recurrence is less frequent 2 years after endovenous laser treatment with a 11% difference compared with high ligation and stripping
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Lay summary
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Not provided at time of registration
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Ethics approval
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Medical Council of the Saarland (Ärztekammer des Saarlandes) Saarbrücken, Germany approved on 29th July 2004, identification-no. 98/2004
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Great saphenous vein insufficiency
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Participants - inclusion criteria
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1. Great saphenous vein (GSV) insufficiency with saphenofemoral incompetence and reflux at least down to the knee level
2. Chronic venous insufficiency and/or symptoms caused by GSV incompetence and/or severe clinical findings at risk of varicose vein bleeding, thrombophlebitis or deep vein thrombosis
3. Age 18 – 65 years (at randomisation)
4. Performance status according to American Society of Anesthesiology (ASA) I-II
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Participants - exclusion criteria
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1. Previous surgical interventions in the groin area with the exception of inguinal herniotomy
2. Anterior or posterior accessory vein incompetence
3. Small saphenous vein insufficiency requiring treatment at the same limb
4. Acute deep venous thrombosis or postthrombotic syndrome
5. Known thrombophilia associated with a high risk of thromboembolism
6. Arterial occlusive disease > Fontaine IIA and/or ankle-brachial index below 0.8
7. Active malignancy (diagnosed during the past 5 years)
8. Poor compliance or missing ability to understand the study related procedures
9. Females pregnant or nursing
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Anticipated start date
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01/09/2004
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Anticipated end date
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31/03/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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Group A : Endovenous Laser Treatment (EVLT): EVLT of the great saphenous vein is performed with an 810 nm Diode laser (bare fibers) using Seldinger's technique ultrasound guided under tumescent local anaesthesia. The energy dose is intended to be 20 J/cm² delivering 20 W laser power. The additional phlebectomy of side branches is allowed.
Group B : High Ligation (Crossectomy) and Stripping (HLS): Standard surgical procedures are performed, consisting of transection of all groin tributaries, flush ligation of the saphenofemoral junction with non-resorbable sutures and neoreflux protection with a continuous stump suture, followed by invagination stripping of the great saphenous vein just below knee under tumescent local anaesthesia. The additional phlebectomy of side branches is allowed.
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Primary outcome measure(s)
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Recurrent varices after surgery (REVAS) evaluated at 12 and 24 months follow up visit.
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Secondary outcome measure(s)
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1. Duplex recurrence
2. Side effects
3. Homburg Varicose Vein Severity Score
4. Chronic Venous Insufficiency Questionnaire
5. Venous Refilling time (DPPG)
6. Patients' satisfaction is measured using visual analogue scale based questionnaires
Follow-up visits are scheduled in the first postoperative week (side effects), at 3 months [side effects, Homburg Varicose Vein Severity Score (HVVSS), Chronic Venous Insufficiency Questionnaire (CIVIQ), Venous refilling time (DPPG), patient's satisfaction], at 12 months [Duplex recurrence, HVVSS, CIVIQ, DPPG, patient's satisfaction] and at 24 months (Duplex recurrence, HVVSS, CIVIQ, DPPG, patient's satisfaction)
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Sources of funding
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Investigator initiated and funded (Germany)
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21931012
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Contact name
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Dr
Knuth
Rass
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Address
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Department of Dermatology, Venerology and Allergology
The Saarland University Hospital
Kirrberger Straße
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City/town
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Homburg
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Zip/Postcode
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66421
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Country
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Germany
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Sponsor
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The Saarland University Hospital (Germany)
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Address
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Department of Dermatology, Venerology and Allergology
c/o Knuth Rass MD
Kirrberger Straße
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City/town
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Homburg
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Zip/Postcode
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66421
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Country
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Germany
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Sponsor website:
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http://www.uniklinikum-saarland.de
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Date applied
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23/04/2011
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Last edited
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27/09/2011
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Date ISRCTN assigned
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19/05/2011
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