FOAM-study veins.

Cost minimization study comparing surgery versus duplex guided foam sclerotherapy of varicose veins: a randomized controlled study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26519

Enrollment

460

Registered

2006-01-31

Start date

2006-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Primary varicose veins due to greater saphenous vein insufficiency

Interventions

1. Standardized duplex guided foam sclerotherapy

2. Standardized surgery procedure.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary trunkal varicositas of the GSV; 2. Age > 18 years; 3. Reflux>0.5 s and insufficiency of the SF-junction measured by duplex; 4. Reflux for at least 20 cm of the GSV in the upper leg; 5. Informed consent; 6. Normal deep venous system.

Exclusion criteria

Exclusion criteria: 1. Signs of DVT found with duplex; 2. Immobility; 3. Allergy for polidocanol in the past; 4. Life-expectation < 3 years; 5. Pregnancy; 6. Abnormal Deep Venous System; 7. Active ulcus cruris.

Design outcomes

Primary

Measure	Time frame
Cumulative probability of recurrent varicose vein at 18-24 months after treatment.	—

Secondary

Measure	Time frame
1. Quality of life (EuroQol-5D); 2. Patient preference; 3. Social costs.	—

Contacts

Public ContactN.H. Shadid

Academic Hospital Maastricht (AZM), P.O. Box 5800

nsh@sder.azm.nl+31 (0)43 3876543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)