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

NCT ID: NCT02397226

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Varicose Veins Venous Insufficiency

Keywords

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Radiofrequency ablation Plethysmography Duplex ultrasound High ligation/stripping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency ablation

Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type PROCEDURE

Radiofrequency ablation catheter

Intervention Type DEVICE

Tumescent anesthesia

Intervention Type PROCEDURE

High ligation/stripping

Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.

Group Type ACTIVE_COMPARATOR

High ligation/stripping

Intervention Type PROCEDURE

General anesthesia

Intervention Type PROCEDURE

Vein stripping catheter

Intervention Type DEVICE

Interventions

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Radiofrequency ablation

Intervention Type PROCEDURE

High ligation/stripping

Intervention Type PROCEDURE

Radiofrequency ablation catheter

Intervention Type DEVICE

Tumescent anesthesia

Intervention Type PROCEDURE

General anesthesia

Intervention Type PROCEDURE

Vein stripping catheter

Intervention Type DEVICE

Other Intervention Names

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Open surgery Covidien ClosureFast Catheter (7cm)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Oskar Nelzén

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helene Zachrisson, Associate Professor, MD

Role: STUDY_CHAIR

Linkoeping University

Oskar Nelzén, MD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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University Hospital Linköping

Linköping, Östergötland County, Sweden

Site Status

Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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Nelzen POE, Skoog J, Oster M, Zachrisson H. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. Phlebology. 2020 Aug;35(7):495-504. doi: 10.1177/0268355519898952. Epub 2020 Jan 20.

Reference Type DERIVED
PMID: 31959059 (View on PubMed)

Other Identifiers

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Varicerstudien

Identifier Type: -

Identifier Source: org_study_id