A Randomised Controlled Trial of Tumescent Anaesthesia in addition to Surgical Ligation and Stripping of the Great Saphenous Vein - RCT of Surgery with tumescent anaesthesia in GSV Stripping

Hull and East Yorkshire Hospitals NHS Trust0 个研究点目标入组 90 人开始时间: 2012年1月5日最近更新: 2020年10月13日

试验速览

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•Patients aged 18 or over • Primary symptomatic superficial venous insufficiency, CEAP grades C2-C6 • SFJ and/or GSV reflux on DUS o Defined as retrograde flow = 1second in duration on spectral Doppler analysis • Suitable to undergo open surgical ligation of the SFJ and stripping of the GSV, with or without ambulatory phlebectomies. • Willing and able to participate and able to give valid, informed written consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•Unsuitability to undergo surgery • Unwillingness/ inability to comply with the requirements for follow-up visits • Known allergy or contraindication to receive any constituents of the study anaesthesia • Varicose veins not due to SFJ or truncal GSV reflux • Pregnant/lactating women • Active Deep Venous Thrombosis/post-thrombotic syndrome of treatment leg • Active or recent (within last 6 weeks) thrombophlebitis of the treatment • Previous ipsilateral varicose vein treatment • Patients with impalpable foot pulses and Ankle-Brachial Pressure Index (ABPI) less than 0.8

发起方

Hull and East Yorkshire Hospitals NHS Trust