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
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

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