Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)
NCT ID: NCT03685838
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-02-13
2022-10-01
Brief Summary
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The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
Detailed Description
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There is currently uncertainty about the use of compression stockings following treatment of varicose veins. International Union of Phlebology (IUP), The Society for Vascular Surgery and the American Venous Forum, as well as 2013 National Institute for Health and Care Excellence (NICE) Guideline on Varicose Veins in the Legs have recommended that compression stockings are suitable in certain clinical indications and can be worn post-operatively for no more than 7 days after interventional treatment to prevent haematoma formation, pain and swelling. However, further research is essential for determining clinical and cost effectiveness, as well as length of time compression should be worn, and level of compression.
Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland. Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandage. To date, the literature on the use of compression stockings following treatment of varicose veins is limited.
Mechano-Chemical Ablation (MOCA) combines mechanical damage to the endothelium caused by a rotating wire with simultaneous catheter-guided infusion of a liquid sclerosant that irreversibly damages the cellular membrane of the endothelium, causing fibrosis of the vein. The exact mechanism is still not exactly known. However, recent experimental research showed that various sclerosants induced apoptosis in the vein wall rather than having an effect restricted to the endothelium. Incomplete loss of endothelial cells and penetration of the sclerosant effect into the media suggest that medial damage is crucial to the success of sclerotherapy and may explain why it is less effective in larger veins. This poses the question whether compression is needed post sclerotherapy to improve contact of the sclerosant to the endothelium when media penetration seems to be more important to allow apoptosis of smooth muscle cells.
The investigators therefore propose to undertake a randomised study looking at the effect of compression therapy after MOCA using Clarivein device
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Compression
Patient will receive Class II above knee compression stockings, and will be asked to wear it for 1 week. This would involve wearing the stocking during daytime but patients will be allowed to take it off at night whilst in bed.
Compression Stockings
Class II above knee compression stockings
No Compression
Patient will not receive any compression stockings.
No interventions assigned to this group
Interventions
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Compression Stockings
Class II above knee compression stockings
Eligibility Criteria
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Inclusion Criteria
* Able to walk unassisted and attend follow-up visits
* Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux \>0.5 seconds on colour Duplex ultrasound
* Able to provide informed consent
Exclusion Criteria
* Patients with a hypercoaguable state
* Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound
* Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality
* Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study
* Patients requiring adjuvant treatment of varicose veins
* Arterial disease (ABPI \< 0.6 and the absence of a palpable pedal pulse)
* Vein diameter \<3mm or \>12mm as measured in the standing position on duplex ultrasound
* Varicose veins unsuitable for MOCA (e.g. very tortuous vein)
* Pregnancy
* Lycra, sclerosant or local anaesthetic allergy
* Patients who have opted for an alternative method of treatment
* Patients with fibromyalgia
* Patients with Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) score of C6 (active ulcer), C1 and C2 (asymptomatic) disease
* Patients with a life expectancy less than 12 months
* Inability or unwillingness to complete questionnaires
* Patients who refuses to participate and unable to provide informed consent or comply with the study protocol.
21 Years
80 Years
ALL
No
Sponsors
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National University of Ireland, Galway, Ireland
OTHER
Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Tang Tjun Yip
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Galway University Hospital
Galway, Galway, Ireland
Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Prof Stewart Walsh
Role: primary
References
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Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53. doi: 10.1136/jech.53.3.149.
Sakurai H, Naito H. A cross-resistance of Pyricularia oryzae Cavara to kasugamycin and blasticidin S. J Antibiot (Tokyo). 1976 Dec;29(12):1341-2. doi: 10.7164/antibiotics.29.1341. No abstract available.
Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203. doi: 10.1067/mva.2002.121985.
van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. No abstract available.
Edwards AG, Baynham S, Lees T, Mitchell DC. Management of varicose veins: a survey of current practice by members of the Vascular Society of Great Britain and Ireland. Ann R Coll Surg Engl. 2009 Jan;91(1):77-80. doi: 10.1308/003588409X358953. Epub 2008 Nov 4.
Fonken LK, Weil ZM, Nelson RJ. Mice exposed to dim light at night exaggerate inflammatory responses to lipopolysaccharide. Brain Behav Immun. 2013 Nov;34:159-63. doi: 10.1016/j.bbi.2013.08.011. Epub 2013 Sep 6.
Elderman JH, Krasznai AG, Voogd AC, Hulsewe KW, Sikkink CJ. Role of compression stockings after endovenous laser therapy for primary varicosis. J Vasc Surg Venous Lymphat Disord. 2014 Jul;2(3):289-96. doi: 10.1016/j.jvsv.2014.01.003. Epub 2014 Feb 14.
Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):500-7. doi: 10.1016/j.ejvs.2009.11.027. Epub 2010 Jan 25.
Whiteley MS, Dos Santos SJ, Fernandez-Hart TJ, Lee CT, Li JM. Media Damage Following Detergent Sclerotherapy Appears to be Secondary to the Induction of Inflammation and Apoptosis: An Immunohistochemical Study Elucidating Previous Histological Observations. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):421-8. doi: 10.1016/j.ejvs.2015.11.011. Epub 2016 Jan 17.
Joyce DP, Walsh SR, Yap CJQ, Chong TT, Tang TY. Compression therapy following ClariVein(R) ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA). Trials. 2019 Dec 5;20(1):678. doi: 10.1186/s13063-019-3787-4.
Other Identifiers
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COMMOCA
Identifier Type: -
Identifier Source: org_study_id