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Tomy; lasercrossectomy versus EVLA

Tomy; lasercrossectomy versus EVLA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24885
Enrollment
100
Registered
2015-06-04
Start date
2016-01-01
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

Recurrence Varicose veins EVLA Lasercrossectomy

Interventions

EVLA and lasercrossectomy

Sponsors

Stichting Centrum Oosterwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients age > 18 3 mm. 5. DUS visible AASV joining the GSV 6. Incompetent SFJ after provocation manoeuvres 7. CEAP C2-C6

Exclusion criteria

Exclusion criteria: 1. Patients age 80 years. 2. Mean diameter of GSV < 0,3 cm 3. GSV not suitable for endovenous ablation 4. AASV not joining the GSV 5. The use of Warfarin or other oral coagulans 6. Risk factors for DVT 7. Competent SFJ. 8. CEAP < 2 9. Patients needing bilateral endovenous GSV treatment

Design outcomes

Primary

MeasureTime frame
Primary Objective: To prove that there is less development of recurrence and neoreflux, caused by AASV incompetence ,originating from the SFJ in the laser crossectomy group than in the traditionally treated EVLA group.

Secondary

MeasureTime frame
Secondary Objectives: The Laser crossectomy procedure is safe with similar risk of thrombotic complications after both treatments. There will be a difference in severity of venous disease and quality of life measurements in favour of laser crossectomy

Contacts

Public ContactS.A. Gauw

Centrum Oosterwal Comeniusstraat 3

s.gauw@fco.nl+31 (072) 5157744

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)