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

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02304146
• Other study ID #: 144144
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2014
• Last updated: December 1, 2014
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Maastricht University Medical Center
• Contact: Yee Lai Lam, M.D.
• Phone: +31433881472
• Email: y.lam[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients included in previous FOAM study

Exclusion Criteria:

• no received informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Varicose Veins

Locations

Country	Name	City	State
Netherlands	Department of Dermatology, Atrium Medical Centre.	Heerlen	Limburg
Netherlands	Maastricht UMC+	Maastricht	Limburg
Netherlands	Departments of Dermatology and Surgery, Laurentius Hospital	Roermond	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term QoL follow-up of patients after UGFS and surgical stripping		6-10 years follow-up	No
Secondary	Clinical recurrence		6-10 years follow-up	No
Secondary	Technical recurrence	Vein closure rates	6-10 years follow-up	No
Secondary	Number of retreatments		6-10 years follow-up	No
Secondary	Venous Clinical Severity Score change		6-10 years follow-up	No