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Completed

NCT Number: NCT03613376

Compression And Functional Ability After Endovenous Varicose Vein Treatment

Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)

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Key information

Conditions

Varicose Veins of Lower Limb Cardiovascular Diseases Varicose Veins Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital, Vascular Department

Oulu, 90220, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
  • Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
  • Distal varicose vein insufficiency suitable for sclerotherapy
  • Patient willingness to participate

Exclusion criteria

  • History of pulmonary embolism or deep venous thrombosis
  • Large (>12mm) truncal vein diameter
  • CEAP C5-C6
  • Antithrombotic medication (ASA accepted)

Treatment and study plan

Class II compression stockings

Other

Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime

Primary outcomes

  1. Post-operative pain

    Time frame: 10days recorded daily

    Visual Analog Scale (VAS) 0-100mm

Secondary outcomes

  1. Functional ability, other than pain

    Time frame: 10 days recorded daily

    Visual Analog Scale 0-100mm indicating post-operative functional ability reduction

  2. Aberdeen Varicose Veins Questionnaire (AVVQ)

    Time frame: Assessed preoperatively and at 2 months

    Score from 0 to 99.658

  3. Visual appearance of varicose veins, patient assessment

    Time frame: Preoperatively and at 2 months

    Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score)

  4. Signs of deep venous thrombosis hematoma

    Time frame: Assessed at 2 months and earlier if necessary

    Ultrasound assessment

  5. Time required returning to normal activity

    Time frame: 14 days

  6. Time required returning to full activity

    Time frame: 14 days

  7. Postoperative pigmentation

    Time frame: at 2 months

    Pigmentation is monitored from standardised photographs on severity of pigmentation and most severe tone of post-operative pigmentation compared to base skin colour, reviewers are blinded to study group.

  8. Visual appearance of varicose veins, expert assessment

    Time frame: Preoperatively and at 2 months

    Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group).

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 3, 2018
Registry last updated
Jan 20, 2021

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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