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N/A N=293 Randomized Diagnostic

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

Varicose Veins

Enrolled (actual)
293
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Rate of Re-do Surgery — 15; 38 legs

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
preoperative duplex examination (Procedure); Preoperative duplex (Procedure)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Uppsala University Hospital
Primary completion
Sep 2003

Outcome Measures

OutcomeResultp-value
PRIMARY
Rate of Re-do Surgery
15; 38
SECONDARY
Recurrence Rate
13; 46

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01195623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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