Clinical trial NCT02890563: Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
Official title: Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: Varicose veins
Compression stockings
Sclerotherapy
Radiofrequency ablation
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.

Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.

Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of pulmonary embolism or deep venous thrombosis
* Large (\>12mm) truncal vein diameter
* CEAP C5-C6
* Patient unwilling to participate

Primary outcomes:
measure: Truncal vein occlusion rate
timeFrame: 6 months
Secondary outcomes:
measure: Post-operative pain assessed with visual analogue scale (VAS)
timeFrame: 10 days
measure: Painkillers usage after treatment
timeFrame: 10 days
measure: Aberdeen Varicose Veins Questionnaire (AVVQ)
timeFrame: 6 months
measure: Compliance with compression stockings
timeFrame: 7 days
measure: Time required returning to normal work and activity level
timeFrame: 14 days
measure: Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
timeFrame: 30days
Other outcomes:
Locations:
city: Raahe
country: Finland
facility: Raahe's hospital
state: Pohjois-Pohjanmaa
city: Oulu
country: Finland
facility: Oulu University Hospital, Vascular Department
Study officials:
affiliation: Oulu University Hospital
name: Toni Pihlaja, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.