Condition category
Circulatory System
Date applied
23/04/2011
Date assigned
19/05/2011
Last edited
01/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Knuth Rass

ORCID ID

Contact details

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

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 measures

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

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

http://www.uniklinikum-saarland.de

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21931012
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26319476

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes