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 |
| Secondary identifying numbers | RELACS v1.7 (10.09.2004) |
- 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
Scientific
Department of Dermatology, Venerology and Allergology
The Saarland University Hospital
Kirrberger Straße
Homburg
66421
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2004 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
66421
Germany
Sponsor information
The Saarland University Hospital (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Dermatology, Venerology and Allergology
c/o Knuth Rass MD
Kirrberger Straße
Homburg
66421
Germany
| Website | http://www.uniklinikum-saarland.de |
|---|---|
"ROR" |
https://ror.org/01jdpyv68 |
Funders
Funder type
Other
Investigator initiated and funded (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
