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Surgery or Noninvasive Therapy for Varicose Veins

NCT ID: NCT00529672

Last Updated: 2010-11-16

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

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Inclusion criteria:

* Ultrasound confirmed GSV insufficiency (reflux time \>0.5 second and vein diameter ≥0.5 cm)
* non-treated GSV varicosis
* CEAP -classification \> C2 and As2
* \>18 years old
* Informed consent.

Exclusion criteria:

* Acute venous thrombosis / phlebitis
* Absence of deep venous system
* Vascular syndromes
* Post-thrombotic syndrome of occlusive type
* Contra-indications for surgery
* use of anticoagulants

Primary outcomes:

1\. anatomical success using US (absence of GSV or flow) (at 3 months, 1 and 5 year)

Secondary outcomes:

1. treatment induced adverse events and complications (after 3 months)
2. patient reported outcomes (HRQOL and treatment satisfaction)(after 3 months)
3. cost effectiveness analyses (after 1 and 5 years)

Included patients: total of 240 (80 per arm)

Study start: May 2007 (recruitment ongoing) Study completion: May 2011

Follow up after 3 months, 1, 2, 3, 4 and 5 years

Location: department of dermatology, Erasmus MC, Rotterdam, The Netherlands

Principle investigators: M. Kockaert, T. Nijsten \& M. Neumann

Publications:

Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. Epub 2007 Jun 27.

Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. Role of endovenous laser treatment in the management of chronic venous insufficiency. Ann Vasc Surg. 2007 Sep;21(5):551-5.

Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg. 2005 Oct;92(10):1189-94.

Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C.Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007 Aug;94(8):925-36.

Subramonia S, Lees TA.The treatment of varicose veins.Ann R Coll Surg Engl. 2007 Mar;89(2):96-100.

Bohler K. Varicose veins: disfigurement or disease? Herz. 2007 Feb;32(1):18-25.

Bamigboye AA, Smyth R. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001066.

van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. New endovenous therapies of truncal varicosities are more effective than surgical stripping and sclerotherapy: meta-analysis and meta-regression. Lancet, Submitted

Conditions

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Varicose Vein

Keywords

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endovenous laser therapy sclerotherapy crossectomy and stripping surgery treatment varicose veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Surgery: crossectomy plus short stripping

Group Type ACTIVE_COMPARATOR

crossectomy and short stripping

Intervention Type PROCEDURE

under spinal or complete anaesthesia

2

ultrasound guided sclerotherapy with foam (3% polidocanol)

Group Type ACTIVE_COMPARATOR

ultrasound guided sclerotherapy with foam

Intervention Type PROCEDURE

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

3

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

Group Type ACTIVE_COMPARATOR

endovenous laser therapy

Intervention Type PROCEDURE

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

Interventions

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endovenous laser therapy

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

Intervention Type PROCEDURE

crossectomy and short stripping

under spinal or complete anaesthesia

Intervention Type PROCEDURE

ultrasound guided sclerotherapy with foam

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* acute thrombosis or phlebitis
* absence of deep venous system
* vascular syndromes
* use of anticoagulants
* contraindications surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Erasmus MC

Principal Investigators

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Martino Neumann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC dermatology

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Michael Kockaert, MD

Role: CONTACT

Phone: 31 10 4634580

Email: [email protected]

Tamar Nijsten, MD, PhD

Role: CONTACT

Phone: 31 10 4631019

Email: [email protected]

Facility Contacts

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Michael Kockaert, MD

Role: primary

Tamar Nijsten, MD, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 26132315 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23769603 (View on PubMed)

Other Identifiers

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2005-325

Identifier Type: -

Identifier Source: org_study_id