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Single Ambulatory Phlebectomy versus endovenous Thermal Ablation with concomitant ambulatory Phlebectomies

Single Ambulatory Phlebectomy versus endovenous Thermal Ablation with concomitant ambulatory Phlebectomies - SAPTAP study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42057
Enrollment
520
Registered
2014-09-17
Start date
2014-09-01
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

saphenous vein varicose veins

Interventions

SAP (with or without delayed EVTA) or TAP with follow-up at 3, 9, 12, and 60 months

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with primary incompetent GSV and tributaries and patients with primary incompetent AASV and tributaries.

Exclusion criteria

Exclusion criteria: previous treatment of ipsilateral GSV trunk or tributary (or in case of AASV, previous treatment of ipsilateral AASV trunk or tributary) deep venous thrombosis and agenesis, post-thrombotic syndrome of the obstructive type, pregnancy and arterial disease.

Design outcomes

Primary

MeasureTime frame
Cost-effectiveness

Secondary

MeasureTime frame
Elimination of reflux in GSV (or AASV), patient reported outcomes (including symptoms, satisfaction and health related quality of life), direct and indirect costs, clinical class of the CEAP classification, venous clinical severity score and predictors of success.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)