Varicose Vein of Lower Limbs Clinical Trial
Official title:
Catheter-directed Foam Sclerotherapy With Tumescence of the Great Saphenous Vein Versus Ultrasound Guided Foam Sclerotherapy: Randomised Controlled Trial
Foam sclerotherapy has been established as another option of treatment for varicose veins of the lower limbs. Its advantages are the application to patients with high surgical risk and immediate return to usual activities. Comparing to laser and radiofrequency, it has lower cost and is less painful. Nevertheless, it requires more re-interventions due to venous recanalization.
The aim of this study is to compare two ultrasound guided foam sclerotherapy (UGFS)
techniques to great saphenous vein (GSV) by injecting the sclerosant foam through a short
catheter without perivenous tumescence and through a long catheter with saline anesthetic
tumescence. Method: selection of 50 patients with primary varicose veins, edema (C3EpAsPr of
the CEAP classification) and with GSV measuring 6 - 10 mm, 3 cm below the saphenofemoral
junction, identified by ultrasound. The study is taking place at the vascular surgery
ambulatory of the University of São Paulo. It is a prospective controlled trial with random
allocation in two groups according to the foam sclerosant technique injection. The group 1
will receive the sclerosant foam by a short catheter 18 G and in the group 2 an angiographic
catheter 4 Fr. will be used. All patients will be treated with 3% polidocanol foam prepared
with a three-way tap and two plastic disposable syringes, according to Tessari's method. The
access will be by puncture and its place will depend on the insufficient venous extension. It
will be at the level of the knee to treat proximal GSV or at the medial ankle to treat the
full length of the vein. In group 2, after inserting the long catheter into the GSV, a saline
anesthetic solution will be infiltrated around the insufficient venous segment under
ultrasound guidance to reduce its diameter. The long catheter will be continuously flushed
with 0.9% saline solution until the foam sclerosant injection. In the cases of treating only
the proximal GSV, patients will receive a continuous compression with tourniquet below the
knee just before the injection and maintained for 5 minutes thereafter. Then, the tributaries
in all 50 patients will be treated by phlebectomy under tumescent local anesthesia.
Color-duplex ultrasound follow-up is programmed to 7, 28 and 168 days after the treatment.
The first one is to check the possibility of deep venous thrombosis, the second is to verify
the occlusion rate and the need of another foam injection. The last ultrasound is to check
the final occlusion rate.
Hypothesis: UGFS with long catheter preceded of tumescence has a large occlusion rate of the
GSV with monotherapy.
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