Surgery or Noninvasive Therapy for Varicose Veins (Magna)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00529672
First received: September 13, 2007
Last updated: November 15, 2010
Last verified: November 2010
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Erasmus Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 28, 2014