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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short catheter | Active Comparator | Twenty-five patients will receive the sclerosant foam by a short catheter 18 G. They will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method. |
|
| Long catheter preceded by tumescence | Experimental | Twenty-five patients will be receive foam sclerosant by an angiographic catheter 4 French. They will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short catheter | Procedure | Ultrasound Guided Foam Sclerotherapy in Great Saphenous Vein, measuring from 6 to 10 mm, with Short Catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Great Saphenous Vein Occlusion Rate | It will be measured by ultrasound | Six months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Change | It will be measured by the application of the Aberdeen varicose vein questionnaire | Six months follow-up after the intervention |
| Complications | It will be considered:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erasmo S Silva, PhD | São Paulo University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18426039 | Result | Breu FX, Guggenbichler S, Wollmann JC. 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37 Suppl 71:1-29. | |
| 19952380 | Result | Cavezzi A, Tessari L. Foam sclerotherapy techniques: different gases and methods of preparation, catheter versus direct injection. Phlebology. 2009 Dec;24(6):247-51. doi: 10.1258/phleb.2009.009061. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 24, 2019 | |
| Reset | Apr 18, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 24, 2019 | Apr 18, 2019 |
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| Long catheter preceded by tumescence | Procedure | Ultrasound Guided Foam Sclerotherapy Transcatheter in Great Saphenous Vein, measuring from 6 to 10 mm, Preceded by Tumescence. |
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| From the intervention until six months follow-up |
| 20922783 | Result | Gohel MS, Epstein DM, Davies AH. Cost-effectiveness of traditional and endovenous treatments for varicose veins. Br J Surg. 2010 Dec;97(12):1815-23. doi: 10.1002/bjs.7256. Epub 2010 Oct 4. |
| 17919946 | Result | Parsi K, Exner T, Connor DE, Ma DD, Joseph JE. In vitro effects of detergent sclerosants on coagulation, platelets and microparticles. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):731-40. doi: 10.1016/j.ejvs.2007.07.011. Epub 2007 Oct 4. |
| 21725957 | Result | Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555. |
| 16226898 | Result | Coleridge-Smith P, Labropoulos N, Partsch H, Myers K, Nicolaides A, Cavezzi A. Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs--UIP consensus document. Part I. Basic principles. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):83-92. doi: 10.1016/j.ejvs.2005.07.019. Epub 2005 Oct 14. |
| 11231246 | Result | Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60. |
| Study Protocol | View IPD |
| Literature Review | View IPD |
| Literature Review | View IPD |
| Literature Review | View IPD |
| Literature Review | View IPD |
| Literature Review | View IPD |