Comparison of Treatments in Venous Insufficiency
|ClinicalTrials.gov Identifier: NCT01298908|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : January 8, 2016
Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.
The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
|Condition or disease||Intervention/treatment|
|Venous Insufficiency||Procedure: Operative treatment Procedure: Laser ablation Procedure: Foam sclerotherapy|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||231 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency|
|Study Start Date :||October 2007|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2015|
Procedure: Operative treatment
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
Other Name: Vein stripping
Ultrasound guided laser ablation
Procedure: Laser ablation
In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
Other Name: Ultrasound guided laser ablation
Ultrasound guided foam sclerotherapy
Procedure: Foam sclerotherapy
Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
Other Name: Ultrasound guided foam sclerotherapy
- Recanalization or reflux of the treated venous trunk [ Time Frame: at 1 and 12 months ]Results will be verified by Duplex scanning
- Symptom relief [ Time Frame: at 1 and 12 months ]Symptoms will be evaluated by using CEAP-classification and degree of disability
- Complications related to procedure [ Time Frame: at 1 and 12 months ]At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded.
- Quality of life [ Time Frame: at 1 and 12 months ]Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298908
|Department of Vascular Surgery, Helsinki University Central Hospital|
|Helsinki, HUS, Finland, 00029|
|Department of Vascular Surgery, Tampere University Hospital|
|Tampere, Finland, 33521|
|Study Director:||Maarit Venermo, MD,PhD||Department of Vascular Surgery, Helsinki University Central Hospital|