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Completed

NCT Number: NCT01195623

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

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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Key information

Conditions

Varicose Veins Cardiovascular Diseases Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases Venous Insufficiency

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capio StGörans Gospital

Stockholm, SE-11821, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative duplex examination

Procedure

Preoperative duplex

Procedure

Primary outcomes

  1. Rate of Re-do Surgery

    Time frame: 7 years mean

    number of reoperations (legs) in the two treatment arms

Secondary outcomes

  1. Recurrence Rate

    Time frame: 7 years

    number of recurrences in treatment arms but also nature of recurrences

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Capio Research Foundation
  • Region Stockholm

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2003
Study completion
2010
First posted
Sep 6, 2010
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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