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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: preoperative duplex examination
* Procedure: Preoperative duplex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: varicose vein surgery with preop duplex<br>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<br> <br> Procedure: Preoperative duplex<br> <br> |
| No Intervention: varicose vein surgery no preop duplex<br>The surgeon has planned surgery for varicose veins from a clinical examination only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Re-do Surgery | number of reoperations (legs) in the two treatment arms | 7 years mean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate | number of recurrences in treatment arms but also nature of recurrences | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose veins, venous insufficiency, surgery, duplex, recurrence