Higher occlusion rate in the EVLA group seen at 1 week postoperative. More recurrences seen in the VNUS group seen at long term. No differences in short term recovery results between both groups.
ID
Bron
Verkorte titel
Aandoening
Recovery, complications, Quality of Life, pain, occlusion- and recurrence rate, tumescent anaesthesia.
Herstel, complicaties, kwaliteit van leven, pijn, herontstaan spataderen na behandeling, tumescentie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Occlusion- and recurrence rate.
Achtergrond van het onderzoek
Early varicose veins are relatively benign but some patients will progress to develop severe problems, including venous ulcers. Endovenous treatments like VNUS-ClosureFAST and Endovenous Laser Ablation are promising procedures for the treatment of trunk vein incompetence. Post operative these treatments give less complications and a better quality of life compared to surgery as stripping. Occlusion - and recurrences rate seen on short and long term is our main outcome parameter. We hypothesize that occlusion rate will be higher in the EVLA group and recurrence rate will be higher in de VNUS group. There will be no difference in quality of life after both treatments.
Doel van het onderzoek
Higher occlusion rate in the EVLA group seen at 1 week postoperative. More recurrences seen in the VNUS group seen at long term. No differences in short term recovery results between both groups.
Onderzoeksopzet
1. 1 week occlusion;
2. Two weeks recovery;
3. Every year recurrence rate, till 5 year after the treatments.
For the measurements VAS-scores are used and questionnaires as the euroqual 5.
Onderzoeksproduct en/of interventie
1. Endovenous Laser Ablation 1470 nm RADIAL fiber;
2. VNUS ClosureFAST.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Incompetence of great saphenous vein, (reflux >0,5 seconds);
2. Lenght of treated vein >15 cm;
3. Diam; >0,3 cm and <1,5 cm;
4. Age >18 year;
5. No primary treatment;
6. CEAP equal or greater than 2;
7. Informed consent procedure.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Primary treatment of great saphenous vein incompetence;
2. Pregnancy;
3. Immobility;
4. Pathology, not willing/able to have local tumescent anaesthesia;
5. Hypersensibility for lidocain;
6. Flebitis in time of surgery;
7. Serpentin-like veins.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2716 |
| NTR-old | NTR2854 |
| Ander register | METC VUmc : 2011/125 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
Menno T. W. Gaastra, MD,a Marco J. Tangelder, MD, PhD,b and Michael C. Mooij, MD. Prospective comparative cohort study evaluating
incompetent great saphenous vein closure using
radiofrequency-powered segmental ablation or
1470-nm endovenous laser ablation with radial-tip
fibers (Varico 2 study). Journal of Vascular Surgery: Venous and Lymphatic Disorders. January 2018. Volume 6, Number 1: 31-40.