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

NCT02397226 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-12-06

No results posted yet for this study

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).

Conditions

  • Varicose Veins
  • Venous Insufficiency

Interventions

PROCEDURE

Radiofrequency ablation

PROCEDURE

High ligation/stripping

DEVICE

Radiofrequency ablation catheter

PROCEDURE

Tumescent anesthesia

PROCEDURE

General anesthesia

DEVICE

Vein stripping catheter

Sponsors & Collaborators

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Helene Zachrisson, Associate Professor, MD · Linkoeping University

  • Oskar Nelzén, MD · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2021-11-25
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397226 on ClinicalTrials.gov