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Completed

NCT Number: NCT02890563

Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. 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 Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raahe's hospital, Raahe, North Ostrobothnia, Finland

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About this study

In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.

Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.

Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
  • Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
  • Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation

Exclusion criteria

  • History of pulmonary embolism or deep venous thrombosis
  • Large (>12mm) truncal vein diameter
  • CEAP C5-C6
  • Patient unwilling to participate

Treatment and study plan

Class II Compression Stockings

Device

Primary outcomes

  1. Truncal vein occlusion rate

    Time frame: 6 months

Secondary outcomes

  1. Post-operative pain assessed with visual analogue scale (VAS)

    Time frame: 10 days

  2. Painkillers usage after treatment

    Time frame: 10 days

    Need for Paracetamol/NSAIDs after treatment

  3. Aberdeen Varicose Veins Questionnaire (AVVQ)

    Time frame: 6 months

    Assessed preoperatively and at one and six months

  4. Compliance with compression stockings

    Time frame: 7 days

    To assess compliance and possible reasons for non-compliance at compression group

  5. Time required returning to normal work and activity level

    Time frame: 14 days

  6. Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively

    Time frame: 30days

    Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2016
Registry last updated
Apr 1, 2019

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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