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NCT Number: NCT02397226

Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases Venous Insufficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Linköping, Linköping, Östergötland County, Sweden

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radiofrequency ablation

Procedure

High ligation/stripping

Procedure

Other names: Open surgery

Radiofrequency ablation catheter

Device

Other names: Covidien ClosureFast Catheter (7cm)

Tumescent anesthesia

Procedure

General Anesthesia

Procedure

Vein stripping catheter

Device

Primary outcomes

  1. Number of treated veins with recanalization using duplex.

    Time frame: 5 years

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

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

    Time frame: 5 years

  3. 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

  1. VCSS score

    Time frame: 5 years

    The score of standardized examination protocol VCSS.

  2. AVVQ score

    Time frame: 5 years

    The score of disease specific questionnaire AVVQ

  3. EQ-5D score

    Time frame: 5 years

    The score of EQ-5D questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2026
First posted
Mar 24, 2015
Registry last updated
Dec 6, 2024

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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