Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
|ClinicalTrials.gov Identifier: NCT02890563|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins||Device: Class II Compression Stockings||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
No Intervention: No Compression
Patients in this group will not receive any compression after treatment.
Active Comparator: Compression
Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).
Device: Class II Compression Stockings
- Truncal vein occlusion rate [ Time Frame: 6 months ]
- Post-operative pain assessed with visual analogue scale (VAS) [ Time Frame: 10 days ]
- Painkillers usage after treatment [ Time Frame: 10 days ]Need for Paracetamol/NSAIDs after treatment
- Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: 6 months ]Assessed preoperatively and at one and six months
- Compliance with compression stockings [ Time Frame: 7 days ]To assess compliance and possible reasons for non-compliance at compression group
- Time required returning to normal work and activity level [ Time Frame: 14 days ]
- Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively [ Time Frame: 30days ]Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890563
|Raahe, Pohjois-Pohjanmaa, Finland, 92101|
|Oulu University Hospital, Vascular Department|
|Oulu, Finland, 90220|
|Principal Investigator:||Toni Pihlaja, M.D.||Oulu University Hospital|