No registrations found.
ID
Source
Brief title
Health condition
Recovery, complications, Quality of Life, pain, occlusion- and recurrence rate, tumescent anaesthesia.
Herstel, complicaties, kwaliteit van leven, pijn, herontstaan spataderen na behandeling, tumescentie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occlusion- and recurrence rate.
Secondary outcome
1. Quality of Life;
2. Complications;
3. Pain.
Background summary
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.
Study objective
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.
Study design
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.
Intervention
1. Endovenous Laser Ablation 1470 nm RADIAL fiber;
2. VNUS ClosureFAST.
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2716 |
| NTR-old | NTR2854 |
| Other | METC VUmc : 2011/125 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
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.