A study to compare outcomes of Sodium tetra-decyl sulphate and Polidocanol in the treatment of varicosities due to incompetent tributaries of superficial vein of leg: a randomized controlled trial

Abstract

Background: Various options for treatment of varicosities of tributaries are mini-phlebectomy, hook phlebectomy, Trivex and sclerotherapy. Sodium tetra-decyl sulphate (STD) and polidocanol (POL) are most commonly used sclerosants. Adverse events caused by sclerosants are pain, thrombophlebitis, hyperpigmentation, allergy, anaphylactic shock, cutaneous necrosis, deep venous thrombosis, headache, visual disturbances and chest tightness. Foam sclerotherapy has been considered to be better than liquid sclerosant. In this study we have compared foam prepared by STD versus POL in the treatment of varicosities of tributaries of superficial vein of Leg.Methods: Patients treated for SFJ or SPJ incompetency post their primary admission and management were attended and evaluated in outpatient department. Patients having varicosities were enrolled for study and treated in OPD by foam sclerotherapy. Patients were randomized to two groups - A or B. Patients were followed up for one month and various clinical outcomes were analyzed.Results: In group A (STD) out of n=20 patients pain, hyperpigmentation and skin necrosis was present in n1=18 patients, n2=14 patients and in n3=2 patients respectively on the first post-operative day while in group B (POL) out of 24 patients it was present in n1=14, n2=8 and n3=1 patient respectively. Post sclerotherapy at one month follow up, in Group A pain and hyperpigmentation decreased to n1=08 and n2=04 patients respectively but skin necrosis was persisting in all n3=02 patients. In-group B pain and hyperpigmentation was present in patients each n1= n2=02 and skin necrosis was present in n3=01 patient.Conclusions: Polidocanol is better than Sodium tetra-decyl sulphate for foam sclerotherapy in terms of better cosmetic outcomes.