Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
1 other identifier
observational
460
1 country
3
Brief Summary
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 11, 2014
CompletedFirst Posted
Study publicly available on registry
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 2, 2014
December 1, 2014
11 months
November 11, 2014
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
long-term QoL follow-up of patients after UGFS and surgical stripping
6-10 years follow-up
Secondary Outcomes (4)
Clinical recurrence
6-10 years follow-up
Technical recurrence
6-10 years follow-up
Number of retreatments
6-10 years follow-up
Venous Clinical Severity Score change
6-10 years follow-up
Study Arms (2)
High ligation and stripping (surgery)
6-10 years post classical stripping of the great saphenous vein.
Foam sclerotherapy
6-10 years post post ultrasound guided foam sclerotherapy of the great saphenous vein.
Eligibility Criteria
Patients who were randomized and received the allocated treatment UGFS or surgical stripping.
You may qualify if:
- all patients included in previous FOAM study
You may not qualify if:
- no received informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Dermatology, Atrium Medical Centre.
Heerlen, Limburg, Netherlands
Maastricht UMC+
Maastricht, Limburg, 6202AZ, Netherlands
Departments of Dermatology and Surgery, Laurentius Hospital
Roermond, Limburg, Netherlands
Related Publications (2)
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.
PMID: 22627969RESULTLam 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.
PMID: 29652081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C.H.A. Wittens, M.D. PhD
Maastricht UMC+
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2014
First Posted
December 1, 2014
Study Start
November 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 2, 2014
Record last verified: 2014-12