NCT00529672

Brief Summary

For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

4 years

First QC Date

September 13, 2007

Last Update Submit

November 15, 2010

Conditions

Varicose Vein

Keywords

endovenous laser therapysclerotherapycrossectomy and strippingsurgerytreatmentvaricose veins

Outcome Measures

Primary Outcomes (1)

  • anatomical success rate (absence or obliteration of GSV on US examination)

    3 months, 1 and 5 years

Secondary Outcomes (3)

  • treatment related adverse events and complications

    3 months, 1 and 5 years

  • patient reported outcomes (HRQOL and treatment satisfaction)

    3 months, 1 and 5 years

  • cost effectiveness analysis

    3 months, 1 and 5 years

Study Arms (3)

1

ACTIVE COMPARATOR

Surgery: crossectomy plus short stripping

Procedure: crossectomy and short stripping

2

ACTIVE COMPARATOR

ultrasound guided sclerotherapy with foam (3% polidocanol)

Procedure: ultrasound guided sclerotherapy with foam

3

ACTIVE COMPARATOR

Endovenous laser therapy (940 nm, about 70 J/cm)

Procedure: endovenous laser therapy

Interventions

crossectomy and short strippingPROCEDURE

under spinal or complete anaesthesia

1
ultrasound guided sclerotherapy with foamPROCEDURE

1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein\>

2
endovenous laser therapyPROCEDURE

940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.

3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary insufficient GSV confirmed by US: reflux\>0.5 sec and diameter\>0.5cm.
  • non-treated insufficient GSV
  • \>18 years
  • informed consent

You may not qualify if:

  • acute thrombosis or phlebitis
  • absence of deep venous system
  • vascular syndromes
  • use of anticoagulants
  • contraindications surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC dermatology

Rotterdam, 3000 CA, Netherlands

RECRUITING

Related Publications (2)

  • van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, Neumann HA, Nijsten T, van den Bos RR. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. 2015 Sep;102(10):1184-94. doi: 10.1002/bjs.9867. Epub 2015 Jul 1.

    PMID: 26132315DERIVED

  • Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.

    PMID: 23769603DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Martino Neumann, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Kockaert, MD

CONTACT

31 10 4634580M.KOCKAERT@ERASMUSMC.NL

Tamar Nijsten, MD, PhD

CONTACT

31 10 4631019t.nijsten@erasmusmc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations

NL(1)