Varicose Veins Clinical Trial
Official title:
Compression And Functional Ability After Endovenous Varicose Vein Treatment
NCT number | NCT03613376 |
Other study ID # | 97/2018 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 21, 2018 |
Est. completion date | January 1, 2021 |
Verified date | January 2021 |
Source | Oulu University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 109 |
Est. completion date | January 1, 2021 |
Est. primary completion date | December 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Finland | Oulu University Hospital, Vascular Department | Oulu |
Lead Sponsor | Collaborator |
---|---|
Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative pain | Visual Analog Scale (VAS) 0-100mm | 10days recorded daily | |
Secondary | Functional ability, other than pain | Visual Analog Scale 0-100mm indicating post-operative functional ability reduction | 10 days recorded daily | |
Secondary | Aberdeen Varicose Veins Questionnaire (AVVQ) | Score from 0 to 99.658 | Assessed preoperatively and at 2 months | |
Secondary | Visual appearance of varicose veins, patient assessment | Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score) | Preoperatively and at 2 months | |
Secondary | Signs of deep venous thrombosis hematoma | Ultrasound assessment | Assessed at 2 months and earlier if necessary | |
Secondary | Time required returning to normal activity | 14 days | ||
Secondary | Time required returning to full activity | 14 days | ||
Secondary | Postoperative pigmentation | 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. | at 2 months | |
Secondary | Visual appearance of varicose veins, expert assessment | Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group). | Preoperatively and at 2 months |
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