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NCT03613376 Clinical Trial

Compression And Functional Ability After Endovenous Varicose Vein Treatment

Varicose Veins Clinical Trial

Official title:
Compression And Functional Ability After Endovenous Varicose Vein Treatment

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date January 2021
Source Oulu University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Finland Oulu University Hospital, Vascular Department Oulu

Sponsors (1)
Lead Sponsor Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
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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