NCT01298908

Comparison of Treatments in Venous Insufficiency

The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. 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. 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. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.

Conditions

• Venous Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Operative treatment	In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
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.
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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-12-01
• Completion: 2015-12-01
• First posted: 2011-02-18
• Last updated: 2016-01-08

Locations

2 sites across 1 country: Finland