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A randomized controlled multicenter trial comparing modern great saphenous vein stripping with crossectomy, with modern great saphenous vein stripping without crossectomy and radiofrequency ablation for primary great saphenous vein incompetence (STRIP trial).

A randomized controlled multicenter trial comparing modern great saphenous vein stripping with crossectomy, with modern great saphenous vein stripping without crossectomy and radiofrequency ablation for primary great saphenous vein incompetence (STRIP trial). - STRIP trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35873
Enrollment
600
Registered
2011-09-26
Start date
2011-07-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Chronic venous insufficiency varicose veins

Interventions

Patients will be enrolled in the outpatient clinic for vascular surgery. Participating patients diagnosed with venous insuffiency of the GSV according to the CEAP classification (appendix protocol)

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients with primary varicosity of the GSV, between age 18-80 year. -CEAP 2-4(Appendix B/VI), without deep vein insufficiency. -Minimum distance between skin and the GSV in the first 20 cm from the SFJ >5mm. -Minimum length of to be treated GSV 10cm. -GSV on one side will be treated in the case of bilateral insufficiency. -GSV will be treated only in the case of solitary GSV insufficiency. -Patients treated by experienced surgeon/center.

Exclusion criteria

Exclusion criteria: -Age 80 years. -Deep vein insufficiency in the same extremity (duplex verified). -Previous thrombosis of the affected limb (secondary thrombosis) -Tortuosity of the GSV, double GSV system. -Superficial veins with a distance of

Design outcomes

Primary

MeasureTime frame
The primary studyparameter will be a clinical recurrence measured by duplex echography at 3,12 and 24 months after intervention.

Secondary

MeasureTime frame
Secondary study parameters will be quality of life as measured by different questionnaires. This study will use the SF-36, EuroQol-5, Aberdeen varicose Vein Questionnaire (AVVQ) and the Pain Disability Index for measuring quality of life. Questionnaires will be completed before and 1, 3, 12, 24 months after intervention. Another secondary parameter which will be evaluated is the cost of the intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)