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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Compression | No Intervention | Patients in this group will not receive any compression after treatment. | |
| Compression | Active Comparator | Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Class II Compression Stockings | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Truncal vein occlusion rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain assessed with visual analogue scale (VAS) | 10 days | |
| Painkillers usage after treatment | Need for Paracetamol/NSAIDs after treatment | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toni Pihlaja, M.D. | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raahe's hospital | Raahe | North Ostrobothnia | 92101 | Finland | ||
| Oulu University Hospital, Vascular Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31753745 | Derived | 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. |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Aberdeen Varicose Veins Questionnaire (AVVQ) | Assessed preoperatively and at one and six months | 6 months |
| Compliance with compression stockings | To assess compliance and possible reasons for non-compliance at compression group | 7 days |
| Time required returning to normal work and activity level | 14 days |
| Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively | Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems). | 30days |
| Oulu |
| 90220 |
| Finland |