Our data suggest that although women are older and present with a more advanced stage of peripheral arterial occlusive disease, endovascular therapy is equally effective irrespective of gender. Surprisingly, the subgroup of young female patients had a specifically poor outcome.
Background:The treatment of chronic venous disease, has largely shifted from high ligation and stripping to endovenous thermal ablation (EVTA) techniques, because of its comparable efficacy and lack of invasiveness. This clinical trial aimed to compare the efficacy of two thermal ablation techniques, endovenous laser ablation (EVLA) 1470-nm with Tulip-Tip TM fiber and radiofrequency ablation (RFA) ClosureFastTM using a noninferiority design for occlusion rate (primary outcome). Methods: A prospective multicenter randomized clinical trial randomized 280 patients for the treatment of great saphenous vein (GSV) reflux. Primary outcome was the GSV occlusion rate, secondary outcome factors were the possible side-effects of the treatment such as pain, ecchymosis, quality of Life (CIVIQ-20), revised Venous Clinical Severity Score (r-VCSS). One-year follow-up period. Results: The total occlusion rates at one year follow-up were 96.4% and 94.5% in the EVLA and RFA groups respectively (P=0.15). Regarding secondary outcomes, such as postoperative CIVIQ-20, r-VCSS, analgesia, absenteeism, there was no significant difference between both treatment groups. Conclusions: RFA and EVLA, using a 1470 nm laser with Tulip-Tip TM fiber, of the GSV results in equal occlusion rates at one year, with comparable postoperative pain and improved quality of life.
IntroductionBreast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.MethodologyAll patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove).Ethics and disseminationThe trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses.Trial registration numberNCT03210311ConclusionThe investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.