‘Comparison of costs and patient reported outcomes of endovenous techniques in the treatment of incompetent saphenous veins;’ A single center, double blinded, randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22362

Enrollment

Registered

2010-02-08

Start date

2010-04-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

varicose veins, endovenous treatment, VNUS, endolaser

Interventions

Treatment of saphenous incompetence with VNUSclosureFAST system, or with the radial fiber 1470 nm endolaser.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary truncal saphenous incompetence; 2. Normal deep venous system; 3. Reflux time > 0.5 s after distal compression in standing position (in GSV or SSV); 4. Patient should be physical able and willing to be treated with one of the two treatments; 5. Age > 18 years; 6. No sex discrimination; 7. Enough knowledge/understanding of the Dutch language; 8. Diameter > 4 mm due to the catheter used in both endovenous techniques.

Exclusion criteria

Exclusion criteria: 1. Signs of DVT- residues visible on duplex; 2. Thrombus in vein of interest; 3. Previous GSV or SSV treatment; 4. Pregnancy; 5. Known malignancy; 6. Known adverse reaction for used local anaesthesia.

Design outcomes

Primary

Measure	Time frame
1. Patient treatment satisfaction in terms of health related quality of life improvement; 2. (Post-operative) pain scores; 3. Clinical changes (venous clinical severity scores and CEAP-classification); 4. (Serious) side effects.	—

Secondary

Measure	Time frame
Direct costs of both treatments.	—

Contacts

Public ContactC. Sobczak

P. Debyelaan 25

C.Sobczak@MUMC.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)