Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RELACS v1.7 (10.09.2004)
Study information
Scientific title
A prospective, Randomised, two-centre study to evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping
Acronym
RELACS
Study hypothesis
Clinical recurrence is less frequent 2 years after endovenous laser treatment with a 11% difference compared with high ligation and stripping
Ethics approval
Medical Council of the Saarland (Ärztekammer des Saarlandes) Saarbrücken, Germany, 29/07/2004, identification-no. 98/2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Great saphenous vein insufficiency
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Recurrent varices after surgery (REVAS) evaluated at 12 and 24 months follow up visit
Secondary outcome measures
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)
Overall trial start date
01/09/2004
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
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
Recruitment start date
01/09/2004
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Germany
Trial participating centre
The Saarland University Hospital
Homburg
66421
Germany
Sponsor information
Organisation
The Saarland University Hospital (Germany)
Sponsor details
Department of Dermatology
Venerology and Allergology
c/o Knuth Rass MD
Kirrberger Straße
Homburg
66421
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21931012
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26319476
Publication citations
-
Results
Rass K, Frings N, Glowacki P, Hamsch C, Gräber S, Vogt T, Tilgen W, Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study)., Arch Dermatol, 2012, 148, 1, 49-58, doi: 10.1001/archdermatol.2011.272.
-
Results
Rass K, Frings N, Glowacki P, Gräber S, Tilgen W, Vogt T, Same Site Recurrence is More Frequent After Endovenous Laser Ablation Compared with High Ligation and Stripping of the Great Saphenous Vein: 5 year Results of a Randomized Clinical Trial (RELACS Study), Eur J Vasc Endovasc Surg, 2015, doi: 10.1016/j.ejvs.2015.07.020.