Abstract
BackgroundThermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD). Despite excellent outcomes, these methods are often associated with pain; generally due to their use of heat and the necessity of fluid infiltration around the vein. More recently, novel non-thermal techniques, such as mechanochemical ablation (MOCA) and cyanoacrylate adhesive (CAE) have been developed to overcome these unwelcome effects. So far, the novel techniques have been found to have similar efficacy to thermal methods, yet no direct comparisons between the non-thermal treatment techniques have been conducted to date, giving rise to this study.Methods/designThis is a prospective, multicentre, randomised clinical trial, recruiting patients with truncal saphenous incompetence. Patients will be randomised to undergo either MOCA or CAE truncal ablation, followed by treatment of any varicosities. All patients will be required to wear compression stockings for 4 days post intervention. The primary outcome measure is the pain score immediately following completion of truncal ablation, measured by a 100-mm Visual Analogue Scale (VAS). The secondary outcomes are entire treatment pain scores, clinical scores, quality of life scores, occlusion rates, time to return to usual activities/work at 2 weeks, 3, 6 and 12 months. Re-intervention rate will be considered from the third month. Cost-effectiveness will be assessed for each intervention at 12 months. The study is powered to detect a mean 10-mm difference in maximum pain score. Allowing for loss to follow-up, the total target recruitment is 180 patients.DiscussionThe study will be the first study to compare MOCA against CAE and is designed to determine which method causes less pain. Completion of this study is expected to be the end of 2019.Trial registrationClinicalTrials.gov, ID: NCT03392753. Registered on 17 November 2017.
Highlights
Thermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD)
Interventions All interventions are performed under ultrasound guidance and local anaesthesia and are carried out by vascular surgeons who are experienced in both methods
Varicose veins are a very common condition associated with detrimental effects on the quality of life (QoL) of patients [2,3,4]
Summary
Thermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD). Occlusion rates of greater than 90% have been demonstrated in studies looking at these two methods at up to 5 years of follow-up [9,10,11,12,13,14] Because these methods make use of thermal energy to denature the venous wall, they have the potential to cause pain, skin burns, skin pigmentation, nerve damage and even arteriovenous fistula formation [15, 16]. To minimise these possible complications and to allow effective treatment, tumescent anaesthesia must be infiltrated around the vein to be treated. This, in turn, can be a source of discomfort to patients
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
