Surgery or Noninvasive Therapy for Varicose Veins - Full Text View

Sponsor:	Erasmus Medical Center
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00529672

Purpose

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.

Condition	Intervention	Phase
Varicose Vein	Procedure: crossectomy and short stripping Procedure: ultrasound guided sclerotherapy with foam Procedure: endovenous laser therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound Varicose Veins

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

anatomical success rate (absence or obliteration of GSV on US examination) [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

treatment related adverse events and complications [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: Yes ]
patient reported outcomes (HRQOL and treatment satisfaction) [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: No ]
cost effectiveness analysis [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Surgery: crossectomy plus short stripping	Procedure: crossectomy and short stripping under spinal or complete anaesthesia
Active Comparator: 2 ultrasound guided sclerotherapy with foam (3% polidocanol)	Procedure: ultrasound guided sclerotherapy with foam 1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
Active Comparator: 3 Endovenous laser therapy (940 nm, about 70 J/cm)	Procedure: endovenous laser therapy 940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529672

Contacts

Contact: Michael Kockaert, MD	31 10 4634580	M.KOCKAERT@ERASMUSMC.NL
Contact: Tamar Nijsten, MD, PhD	31 10 4631019	t.nijsten@erasmusmc.nl

Locations

Netherlands
Erasmus MC dermatology	Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Michael Kockaert, MD 31 10 4634580 m.kockaert@erasmusmc.nl
Contact: Tamar Nijsten, MD, PhD 31 10 4631019 t.nijsten@ersmusmc.nl
Sub-Investigator: Prof. sambeek, MD, PhD

Sponsors and Collaborators

Erasmus Medical Center

Investigators

Principal Investigator:

Martino Neumann, MD, PhD

Erasmus MC

More Information

No publications provided

Responsible Party:	Dr. TEC Nijsten, Erasmus MC
ClinicalTrials.gov Identifier:	NCT00529672 History of Changes
Other Study ID Numbers:	2005-325
Study First Received:	September 13, 2007
Last Updated:	November 15, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:

endovenous laser therapy
sclerotherapy
crossectomy and stripping

surgery
treatment
varicose veins

Additional relevant MeSH terms:

Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 13, 2012