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

• Conditions: Varicose Veins

• Registration Number: NCT02304146
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-25
• Status Verified: 2014-12
• Study First Posted: 2014-12-01
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• all patients included in previous FOAM study

Exclusion Criteria

• no received informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
long-term QoL follow-up of patients after UGFS and surgical stripping	6-10 years follow-up

Secondary Outcome Measures

Name	Time	Method
Technical recurrence	6-10 years follow-up	Vein closure rates
Clinical recurrence	6-10 years follow-up
Number of retreatments	6-10 years follow-up
Venous Clinical Severity Score change	6-10 years follow-up

Trial Locations

Locations (3)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands

Departments of Dermatology and Surgery, Laurentius Hospital; 🇳🇱 Roermond, Limburg, Netherlands

Department of Dermatology, Atrium Medical Centre.; 🇳🇱 Heerlen, Limburg, Netherlands