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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

September 3, 2010
February 13, 2013
November 1997
September 2003   (final data collection date for primary outcome measure)
Rate of Re-do Surgery [ Time Frame: 7 years mean ] [ Designated as safety issue: No ]
number of reoperations (legs) in the two treatment arms
Rate of re-do surgery [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01195623 on ClinicalTrials.gov Archive Site
Recurrence Rate [ Time Frame: 7 years ] [ Designated as safety issue: No ]
number of recurrences in treatment arms but also nature of recurrences
recurrence rate [ Designated as safety issue: No ]
number of recurrences in treatment arms but also nature of recurrences
Not Provided
Not Provided
 
The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins
Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Varicose Veins
  • Procedure: preoperative duplex examination
  • Procedure: Preoperative duplex
  • 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
    Interventions:
    • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
293
August 2010
September 2003   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01195623
ETKI 96-169
No
Lena Blomgren, Uppsala University Hospital
Uppsala University Hospital
  • Capio Research Foundation
  • Stockholm County Council, Sweden
Not Provided
Uppsala University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP