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

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Varicose Veins

Study type: Observational

Funder types: Other

Identifiers

NCT02304146

144144

Details and patient eligibility

About

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

Full 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.

Enrollment: 460 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all patients included in previous FOAM study

Exclusion criteria

• no received informed consent

Trial design

460 participants in 2 patient groups

High ligation and stripping (surgery)

Description:

6-10 years post classical stripping of the great saphenous vein.

Foam sclerotherapy

Description:

6-10 years post post ultrasound guided foam sclerotherapy of the great saphenous vein.