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Clinical Trials/NCT03613376
NCT03613376
Completed
Not Applicable

Compression And Functional Ability After Endovenous Varicose Vein Treatment

Oulu University Hospital1 site in 1 country109 target enrollmentMay 21, 2018
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ConditionsVaricose Veins of Lower LimbVaricose Veins

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Varicose Veins of Lower Limb
Sponsor
Oulu University Hospital
Enrollment
109
Locations
1
Primary Endpoint
Post-operative pain
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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)

Registry
clinicaltrials.gov
Start Date
May 21, 2018
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Toni Pihlaja

Vascular specialist

Oulu University Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Post-operative pain

Time Frame: 10days recorded daily

Visual Analog Scale (VAS) 0-100mm

Secondary Outcomes

  • Aberdeen Varicose Veins Questionnaire (AVVQ)(Assessed preoperatively and at 2 months)
  • Time required returning to full activity(14 days)
  • Postoperative pigmentation(at 2 months)
  • Functional ability, other than pain(10 days recorded daily)
  • Visual appearance of varicose veins, patient assessment(Preoperatively and at 2 months)
  • Signs of deep venous thrombosis hematoma(Assessed at 2 months and earlier if necessary)
  • Time required returning to normal activity(14 days)
  • Visual appearance of varicose veins, expert assessment(Preoperatively and at 2 months)

Study Sites (1)

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