Clinical trial NCT02304146: Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
Official title: Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Keywords: Foam
UGFS
Stripping
Incompetence
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-12-01
Enrollment: 460
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were randomized and received the allocated treatment UGFS or surgical stripping.

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.

Eligibility criteria: Inclusion Criteria:

* all patients included in previous FOAM study

Exclusion Criteria:

* no received informed consent

Primary outcomes:
measure: long-term QoL follow-up of patients after UGFS and surgical stripping
timeFrame: 6-10 years follow-up
Secondary outcomes:
measure: Clinical recurrence
timeFrame: 6-10 years follow-up
measure: Technical recurrence
timeFrame: 6-10 years follow-up
measure: Number of retreatments
timeFrame: 6-10 years follow-up
measure: Venous Clinical Severity Score change
timeFrame: 6-10 years follow-up
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Department of Dermatology, Atrium Medical Centre.
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Roermond
country: Netherlands
facility: Departments of Dermatology and Surgery, Laurentius Hospital
state: Limburg
Study officials:
affiliation: Maastricht UMC+
name: C.H.A. Wittens, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
citation: Lam YL, Lawson JA, Toonder IM, Shadid NH, Sommer A, Veenstra M, van der Kleij AMJ, Ceulen RP, de Haan E, Ibrahim F, van Dooren T, Nieman FH, Wittens CHA. Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein. Br J Surg. 2018 May;105(6):692-698. doi: 10.1002/bjs.10762.