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

This study has been completed.
Sponsor:
Collaborators:
Capio Research Foundation
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Lena Blomgren, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01195623
First received: September 3, 2010
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Varicose Veins
U.S. FDA Resources

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Rate of Re-do Surgery [ Time Frame: 7 years mean ] [ Designated as safety issue: No ]
    number of reoperations (legs) in the two treatment arms


Secondary Outcome Measures:
  • Recurrence Rate [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 3, 2010
Results First Received: June 14, 2012
Last Updated: February 13, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013