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
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Varicose Veins
Interventions: Procedure: preoperative duplex examination
Procedure: Preoperative duplex

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Varicose Vein Surgery With Preoperative 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
Varicose Vein Surgery Without Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination only

Participant Flow:   Overall Study
    Varicose Vein Surgery With Preoperative Duplex     Varicose Vein Surgery Without Preoperative Duplex  
STARTED     148 [1]   145 [2]
COMPLETED     113 [3]   108 [4]
NOT COMPLETED     35     37  
Lost to Follow-up                 35                 37  
[1] 166 legs total operated
[2] 177 legs total operated
[3] 127 legs
[4] 129 legs



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varicose Vein Surgery With Preoperative 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
Varicose Vein Surgery Without Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination only
Total Total of all reporting groups

Baseline Measures
    Varicose Vein Surgery With Preoperative Duplex     Varicose Vein Surgery Without Preoperative Duplex     Total  
Number of Participants  
[units: participants]
  148     145     293  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 10.6     52.6  ± 12.9     54  ± 11  
Gender  
[units: participants]
     
Female     108     109     217  
Male     40     36     76  
Region of Enrollment  
[units: participants]
     
Sweden     148     145     293  



  Outcome Measures
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1.  Primary:   Rate of Re-do Surgery   [ Time Frame: 7 years mean ]

2.  Secondary:   Recurrence Rate   [ Time Frame: 7 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The rate of hand-held Doppler device use was not known and may have influenced the results, however even now many Swedish surgeons plan varicose vein surgery clinical tests only


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