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Clinical Trials/NCT02397226
NCT02397226Active, not recruitingNot Applicable

Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D

University Hospital, Linkoeping4 sites in 1 country198 target enrollmentStarted: September 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
198
Locations
4
Primary Endpoint
Number of treated veins with recanalization using duplex.

Study Overview

Brief Summary

200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Insufficient great saphenous vein
  • Possible to treat with both radiofrequency ablation and high ligation/stripping
  • Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6

Exclusion Criteria

  • Previous intervention in the affected leg
  • Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
  • Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
  • Patient that is not able to perform plethysmography

Outcomes

Primary Outcomes

Number of treated veins with recanalization using duplex.

Time Frame: 5 years

Flow detected by duplex at the site of the treated vein.

Number of treated limbs with neovascularization using duplex and/or plethysmography.

Time Frame: 5 years

Prediction of treatment outcome using plethysmography with superficial shut-down.

Time Frame: 1 month postoperatively

If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.

Secondary Outcomes

  • VCSS score(5 years)
  • AVVQ score(5 years)
  • EQ-5D score(5 years)

Investigators

Sponsor
University Hospital, Linkoeping
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oskar Nelzén

MD, PhD

University Hospital, Linkoeping

Study Sites (4)

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