Abstract
BackgroundEndovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.Methods/DesignThe Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1 year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.DiscussionThe aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.Trial registrationClinicalTrials.gov identifier: NCT02627846, registered 8 December 2015EudraCT number: 2015-000730-30REC ref: 15/YH/0207R&D ref: R1788
Highlights
Endovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins
The aim of the Laser Ablation versus Mechanochemical Ablation (LAMA) trial is to establish whether mechanochemical ablation (MOCA) is superior to the current first-line treatment, EVLA
The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures
Summary
Endovenous techniques have revolutionised the treatment of truncal varicose veins, and endovenous thermal ablation has become the recommended first-line treatment method [4], achieving occlusion rates of greater than 90 % [11]. The search for the optimum treatment method is still ongoing and recent emphasis has focused on improving outcomes such as intra- and post-procedural pain, and reducing thermal-related injury and complications. A potential solution to the problems raised by endovenous thermal ablation is the use of newer non-thermal and nontumescent anaesthesia treatment methods such as MOCA. The aim of the present randomised clinical trial is twofold. The first hypothesis is that MOCA may cause less initial pain and disability, allowing a more acceptable treatment with an enhanced recovery. The LAMA trial is a randomised controlled trial that aims for reduction in intra- and postprocedural pain after MOCA compared with EVLA, with a similar clinical success and technical efficacy. By the end of December 2015, 75 patients had provided written informed consent and were subsequently randomised to either treatment
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