Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.
In this study there are no additional risk factors for the included study patients except the risk of surgery.
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Oberösterreich
-
Linz, Oberösterreich, Østerrike, 4020
- Rekruttering
- 2.Chirurgische Abteilung AKh Linz GesmbH
-
Ta kontakt med:
- Katharina Bröderbauer
- Telefonnummer: 0043 732 7806 2133
- E-post: chirurgie2@akh.linz.at
-
Hovedetterforsker:
- Markus MS Schreiner
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
- maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm
Exclusion Criteria:
- surgical treatment of the saphenous vein in the past
- sclerotherapy of the saphenous vein in the past
- phlebitis or thrombosis of the saphenous vein
- surgical treatment of an venous ulcer in the past
- postthrombotic syndrome
- erysipelas of the leg in the past
- chronic treatment with pain-killers or chronic alcoholism
- pregnancy
- drug allergy against painkillers that are used in this study
- spinal anesthesia not possible
- compression bandage not possible
- patients with polyneuropathy
- patients with chronic pain
- persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
- participation on an other clinical trial that can interfere with this clinical trial
- missing written informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 1470nm Laser
Patient with varicose vein treated with 1470nm Laser (Biolitec)
|
Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
|
|
Aktiv komparator: VNUS Closure Fast
Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
|
Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain
Tidsramme: day 0
|
Pain (visual analogue scale) on the day of treatment
|
day 0
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Obliteration of the treated vein (GSV or SSV)
Tidsramme: day 10, month 3, month 12
|
An ultrasound investigation of he treated vein is done to find out if the treated vein is fully obliterated or not.
If it is not fully obliterated we want to find out if there is any pathological reflux in the vein.
|
day 10, month 3, month 12
|
|
Patient´s satisfaction after the intervention
Tidsramme: day 10, month 3, month 12
|
The patient is asked about his/her satisfaction after intervention.
This is measured on a numeric scale from 1 to 5 (like schoolmarks in austria or germany).
1=very good, 2=good, 3=average, 4=not so good, 5=bad)
|
day 10, month 3, month 12
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
paresthesia of the lower leg after intervention
Tidsramme: day 10, month 3, month 12
|
patients are asked if there is any paresthesia of the lower leg - "yes" or "no"
|
day 10, month 3, month 12
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Markus Schreiner, 2.Chirurgische Abteilung AKh Linz GesmbH
- Studiestol: Andreas Shamiyeh, 2. Chirurgische Abteilung AKh Linz GesmbH
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Boltzmann-001
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