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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Study Completion Date

2010-08-31

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.

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Detailed Description

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Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

preoperative duplex examination

Intervention Type PROCEDURE

Preoperative duplex

Intervention Type PROCEDURE

varicose vein surgery no preop duplex

The surgeon has planned surgery for varicose veins from a clinical examination only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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preoperative duplex examination

Intervention Type PROCEDURE

Preoperative duplex

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No