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Trial record 4 of 481 for:    varicose veins

The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195623
First Posted: September 6, 2010
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Capio Research Foundation
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Lena Blomgren, Uppsala University Hospital
  Purpose
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.

Condition Intervention
Varicose Veins Procedure: preoperative duplex examination Procedure: Preoperative duplex

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up

Resource links provided by NLM:


Further study details as provided by Lena Blomgren, Uppsala University Hospital:

Primary Outcome Measures:
  • Rate of Re-do Surgery [ Time Frame: 7 years mean ]
    number of reoperations (legs) in the two treatment arms


Secondary Outcome Measures:
  • Recurrence Rate [ Time Frame: 7 years ]
    number of recurrences in treatment arms but also nature of recurrences


Enrollment: 293
Study Start Date: November 1997
Study Completion Date: August 2010
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varicose vein surgery with preop duplex
The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
Procedure: preoperative duplex examination Procedure: Preoperative duplex
No Intervention: varicose vein surgery no preop duplex
The surgeon has planned surgery for varicose veins from a clinical examination only

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with primary varicose veins

Exclusion Criteria:

  • pure cosmetic complaints
  • previous venous surgery or sclerotherapy
  • history of suspect or manifest deep venous thrombosis
  • active or healed venous ulceration
  • peripheral arterial disease
  • previous significant trauma to the leg
  • general illness
  • alcohol or drug abuse
  • unable to understand information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195623


Locations
Sweden
Capio StGörans Gospital
Stockholm, Sweden, SE-11821
Sponsors and Collaborators
Uppsala University Hospital
Capio Research Foundation
Stockholm County Council, Sweden
  More Information

Publications:
Responsible Party: Lena Blomgren, MD, PhD, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01195623     History of Changes
Other Study ID Numbers: ETKI 96-169
First Submitted: September 3, 2010
First Posted: September 6, 2010
Results First Submitted: June 14, 2012
Results First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Lena Blomgren, Uppsala University Hospital:
varicose veins
venous insufficiency
surgery
duplex
recurrence

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases