Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
1 other identifier
interventional
200
1 country
2
Brief Summary
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 1, 2019
March 1, 2019
2.6 years
August 31, 2016
March 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Truncal vein occlusion rate
6 months
Secondary Outcomes (6)
Post-operative pain assessed with visual analogue scale (VAS)
10 days
Painkillers usage after treatment
10 days
Aberdeen Varicose Veins Questionnaire (AVVQ)
6 months
Compliance with compression stockings
7 days
Time required returning to normal work and activity level
14 days
- +1 more secondary outcomes
Study Arms (2)
No Compression
NO INTERVENTIONPatients in this group will not receive any compression after treatment.
Compression
ACTIVE COMPARATORPatients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).
Interventions
Eligibility Criteria
You may qualify if:
- Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
- Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
- Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation
You may not qualify if:
- History of pulmonary embolism or deep venous thrombosis
- Large (\>12mm) truncal vein diameter
- CEAP C5-C6
- Patient unwilling to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Raahe's hospital
Raahe, North Ostrobothnia, 92101, Finland
Oulu University Hospital, Vascular Department
Oulu, 90220, Finland
Related Publications (1)
Pihlaja T, Romsi P, Ohtonen P, Jounila J, Pokela M. Post-procedural Compression vs. No Compression After Radiofrequency Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A Randomised Controlled Non-inferiority Trial. Eur J Vasc Endovasc Surg. 2020 Jan;59(1):73-80. doi: 10.1016/j.ejvs.2019.08.020. Epub 2019 Nov 18.
PMID: 31753745DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toni Pihlaja, M.D.
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 7, 2016
Study Start
August 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
April 1, 2019
Record last verified: 2019-03