VARICO TRIAL, Prospective randomised trial to analyse short and long term results of stripping versus endovenous laser treatment of long saphenous vein incompetence under local anaesthesia.

VARICO TRIAL, Prospective randomised trial to analyse short and long term results of stripping versus endovenous laser treatment of long saphenous vein incompetence under local anaesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25507

Enrollment

274

Registered

2008-03-04

Start date

2008-02-25

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

Recurrence of varicosis. Endovenous laser technique versus stripping Local anaesthesia Treatment of the long saphenous vein incompetence

Interventions

- Stripping method - Endovenous laser therapy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Long saphenous vein (LSV) incompetence (duplex: reflux > 0,5 sec. measured and seen in standing position by manual compression or valsalva manouvre) 2. Diameter of LSV equal or more than 0,3 cm and equal or less than 1,5 cm 3. Length of LSV traject more than 15 cm intrafascial 4. No earlier operations 5. Age between 18-70 years 6. CEAP classification equal or more than C2 7. Informed consent

Exclusion criteria

Exclusion criteria: 1. Patient does not meet the therefore mentioned inclusion criteria 2. Pregnancy 3. Immobility 4. Pathology deep venous system 5. Patients don't wish to be operated under local anaesthesia 6. Proven reaction on lidocaine 7. Contra indications to stop Clopidogrel or coumarine or that can not be stopped or temporarely replaced by fraxiparine 8. Flebitis in time of surgery

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the recurrence rate of the varicose vein.	—

Secondary

Measure	Time frame
Secondary endpoints are complicatons and quality of life.	—

Contacts

Public ContactR. Pullens

r.pullens@centrum-oosterwal.nl072-5157744

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)