Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|