Our hypothesis is that SAP is a cost-effective alternative to TAP. SAP will suffice in gaining a good clinical outcome without ablating the GSV in 2/3 of eligible patients after one year.
ID
Bron
Verkorte titel
Aandoening
great saphenous vein reflux, great saphenous vein insufficiency, single phlebectomies, isolated phlebectomies
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cost-effectiveness
Doel van het onderzoek
Our hypothesis is that SAP is a cost-effective alternative to TAP. SAP will suffice in gaining a good clinical outcome without
ablating the GSV in 2/3 of eligible patients after one year.
Onderzoeksopzet
Baseline, 3 months, 9 months and 1 year of follow up
Onderzoeksproduct en/of interventie
Single ambulatory phlebectomies versus endovenous thermal ablation with concomitant ambulatory phlebectomies
Publiek
Postbus 2040
S.K. Velden, van der
Rotterdam 3000 CA
The Netherlands
010-7040110
s.vandervelden@erasmusmc
Wetenschappelijk
Postbus 2040
S.K. Velden, van der
Rotterdam 3000 CA
The Netherlands
010-7040110
s.vandervelden@erasmusmc
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients >18 years
- Symptoms of chronic venous disease, including complaints related to varicose veins (patients with > C2)
- Reflux (defined as duration of reverse flow >0.5) of the AASV or GSV (at least above knee level) and refluxing tributaries at the level of the thigh (not lower than 5cm below the knee)
- Minimal length of refluxing segment > 5cm
- Diameter of the GSV or AASV ≥ 3 mm (measured in its tubular part of GSV or AASV, at mid thigh level in case of a GSV or at 3 cm below the SFJ in case of an AASV, not at focal dilatation)
- Tributaries are considered suitable for phlebectomy (in practice ≥ 3 mm)
- Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous treatment of the ipsilateral GSV (or in case of AASV, previous treatment of the ipsilateral AASV) or tributaries
- Non-isolated incompetence of the AASV or GSV of the ipsilateral leg
- Previous high ligation of the SFJ
- Acute deep or superficial vein thrombosis
- Agenesis of the deep venous system
- Vascular malformations
- Post-thrombotic syndrome (reflux type or obstructive type)
- Pregnancy
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4670 |
| NTR-old | NTR4821 |
| CCMO | NL49701.078.14 |
| OMON | NL-OMON42057 |