NCT02304146

Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 460 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.

Detailed description

It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis. Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s. The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.

Conditions

• Varicose Veins

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-12-01
• Last updated: 2014-12-02

Locations

3 sites across 1 country: Netherlands