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

Uppsala University Hospital

Status: Completed

Conditions: Varicose Veins

Treatments: Procedure: preoperative duplex examination; Procedure: Preoperative duplex

Study type: Interventional

Funder types: Other

Identifiers

NCT01195623

ETKI 96-169

Details and patient eligibility

About

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.

Enrollment: 293 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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293 participants in 2 patient groups

varicose vein surgery with preop duplex

Active Comparator group

Description:

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

Treatment:

Procedure: Preoperative duplex

Procedure: preoperative duplex examination

varicose vein surgery no preop duplex

No Intervention group

Description:

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