Abstract
Background
Endovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. But it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have some advantages such as less post-procedural pain and less procedure time . MOCA combines physical damage to endothelium using sharply terminated metal claws, with the injection of a liquid sclerosant.
Introduction
Chronic venous insufficiency is one of the most common medical conditions among highly developed societies. The majority of patients (70%) suffer from saphenous veins incompetency. The aim of this study was to evaluate the primary efficacy of mechanochemical sclerotherapy by phlebogriffe (flebogrif) in comparison to laser ablation in treatment of varicose vein.
Methods/Design
The study was conducted on 30 patients, including 16 women and 14 men divided into 2 groups. The first group (15 patients) was treated with ablation with Flebogrif (MOCA) to treat varicose veins. The second group (15 patients) was treated with ablation with Endovenous laser ablation (EVLA). All patients were qualified based on the ultrasound in a standing position confirming incompetence of the great saphenous vein or small saphenous vein. 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, bruising, complications, satisfaction, 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.
Results
The total primary obliteration rate after 3 days and 1 month was 100% with both EVLA-RTF and MOCA while after 3 months (ms) was 93.3% with both groups. After 6ms the total primary obliteration rate was 93.3% with EVLA-RTF and 86.7% with MOCA. The Venous Clinical Severity Score (VCSS) presented similar and durable improvements in both groups between 3days and 6 months. While there is significant less post procedural pain, ecchymosis and bruises with the MOCA method and so high incidence of use of analgesics in EVLA patients than in MOCA group. The median time for return to work was 1 day after both treatments. No severe adverse events were observed.
Discussion
The aim of the study is to evaluate whether MOCA is superior to EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing rapid post-operative recovery. The second hypothesis is the efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.
Conclusions
EVLA and MOCA have similarly high great saphenous vein (GSV) obliteration rates in the long term, and the treatments are equally effective clinically. While according to post procedural pain, ecchymosis, Bruises and long procedural time. The study showed significant high incidence of occurrence in EVLA group than MOCA group. So according to these items there is significant superiority of MOCA over EVLA.
A randomized prospective long-term (>1 year) clinical trial comparing the efficacy and safety of radiofrequency ablation to 980 nm laser ablation of the great saphenous vein
