Compression And Functional Ability After Endovenous Varicose Vein Treatment

Not Applicable

Completed

• Conditions: Varicose Veins of Lower Limb; Varicose Veins

• Registration Number: NCT03613376
• Lead Sponsor: Oulu University Hospital

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2018-07-29
• Study First Posted: 2018-08-03
• Primary Completion: 2020-12-21
• Status Verified: 2021-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative pain	10days recorded daily	Visual Analog Scale (VAS) 0-100mm

Secondary Outcome Measures

Name	Time	Method
Aberdeen Varicose Veins Questionnaire (AVVQ)	Assessed preoperatively and at 2 months	Score from 0 to 99.658
Time required returning to full activity	14 days
Postoperative pigmentation	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.
Functional ability, other than pain	10 days recorded daily	Visual Analog Scale 0-100mm indicating post-operative functional ability reduction
Visual appearance of varicose veins, patient assessment	Preoperatively and at 2 months	Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score)
Signs of deep venous thrombosis hematoma	Assessed at 2 months and earlier if necessary	Ultrasound assessment
Time required returning to normal activity	14 days
Visual appearance of varicose veins, expert assessment	Preoperatively and at 2 months	Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group).

Trial Locations

Locations (1)

Oulu University Hospital, Vascular Department; 🇫🇮 Oulu, Finland