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

NCT ID: NCT02304146

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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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 0ยท5 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.

Conditions

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Varicose Veins

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High ligation and stripping (surgery)

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

No interventions assigned to this group

Foam sclerotherapy

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all patients included in previous FOAM study

Exclusion Criteria

* no received informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C.H.A. Wittens, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC+

Locations

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Department of Dermatology, Atrium Medical Centre.

Heerlen, Limburg, Netherlands

Site Status RECRUITING

Maastricht UMC+

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Departments of Dermatology and Surgery, Laurentius Hospital

Roermond, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Yee Lai Lam, M.D.

Role: CONTACT

[email protected]
+31433881472

Facility Contacts

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J.J. van der Kleij, M.D.

Role: primary

Yee Lai Lam, M.D.

Role: primary

E de Haan, M.D.

Role: primary

References

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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.

Reference Type RESULT
PMID: 22627969 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29652081 (View on PubMed)

Other Identifiers

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144144

Identifier Type: -

Identifier Source: org_study_id