To evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping

ISRCTN	ISRCTN18322872
DOI	https://doi.org/10.1186/ISRCTN18322872
Protocol serial number	RELACS v1.7 (10.09.2004)
Sponsor	The Saarland University Hospital (Germany)
Funder	Investigator initiated and funded (Germany)

Submission date: 23/04/2011
Registration date: 19/05/2011
Last edited: 01/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Knuth Rass
Scientific

Department of Dermatology, Venerology and Allergology
The Saarland University Hospital
Kirrberger Straße
Homburg
66421
Germany

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A prospective, Randomised, two-centre study to evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping
Study acronym	RELACS
Study objectives	Clinical recurrence is less frequent 2 years after endovenous laser treatment with a 11% difference compared with high ligation and stripping
Ethics approval(s)	Medical Council of the Saarland (Ärztekammer des Saarlandes) Saarbrücken, Germany, 29/07/2004, identification-no. 98/2004
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Recurrent varices after surgery (REVAS) evaluated at 12 and 24 months follow up visit
Key secondary outcome measure(s)	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)
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	01/09/2004
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

Germany

Study participating centre

The Saarland University Hospital

Homburg
66421
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No
Results article	results	01/11/2015		Yes	No