[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphedema-of-leg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphedema-of-leg":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100522417","the-n-lva-study-rct-comparing-lva-vs-sham-surgery-in-cancer-related-lymphedema-100522417",false,"NCT06082349","The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema","Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;\n* Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;\n* Unilateral lymphedema;\n* Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);\n* Refractory lymphedema that underwent at least three months of conservative treatment;\n* Informed consent.\n\nExclusion Criteria:\n\n* History of lymphatic reconstruction in the past 10 years;\n* Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and\u002For fibrosis;\n* Patients with active distant metastases, treated with palliative intent;\n* Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and\u002For chemotherapy. Note: patients receiving adjuvant targeted and\u002For endocrine treatment are eligible;\n* Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;\n* Active infection in the lymphedematous extremity;\n* Bilateral lymphedema;\n* Lymphedema present in genital or breast area only;\n* Primary lymphedema;\n* Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score.\n\nA total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.",[26,27,28,29,30],"Lymphedema, Secondary","Lymphedema of Upper Limb","Lymphedema, Lower Limb","Lymphedema Arm","Lymphedema of Leg",[32,33,34,35],"Lymphaticovenous anastomosis","Sham surgery","Microsurgery","LVA","RECRUITING","2026-01-15",{"date":39,"type":40},"2026-01-16","ACTUAL",{"date":42,"type":40},"2023-12-18",{"date":44,"type":20},"2029-03-01",{"name":46,"class":47},"Maastricht University Medical Center","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100598599","effect-of-lymphovenous-anastomosis-on-lower-limb-lymphedema-pragmatic-randomized-controlled-trial-100598599","NCT07073586","Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial","Protocol: Effect of Lymphovenous Anastomosis in the Treatment of Lower Limb Lymphedema - Pragmatic Assessor-Blinded Open-Label Randomized Controlled Trial (PrCT)","Inclusion Criteria:\n\n* LLL International Society of Lymphology (ISL) stage 1-2a (both primary and secondary lymphedema and both unilateral and bilateral)\n* Cancer-free with no recurrence for at least one year\n* Age 18 or above\n* Circumference of the affected leg is at least 1 cm larger than the non-lymphedema leg at the most affected site of lymphedema.\n* Proficiency in Danish language, and ability to provide informed consent.\n* Dermal Backflow Stage 0-4\n\nExclusion Criteria:\n\n* LLL International Society of Lymphology (ISL) stage 2b-3\n* Medical conditions contraindicating surgical intervention or anesthesia, such as severe heart or lung disease\n* Allergy to ICG\n* Ongoing infections or skin diseases in the affected limb\n* Previous surgery or other treatment modalities that could interfere with the study results (previous LVA, liposuction or similar).\n* Dermal Backflow Stage 5\n* Active cancer\n* Heart or kidney conditions that can cause leg swelling\n* A BMI above 28 kg\u002Fm²\n* Current smoker\n* Any foreign objects in the lower extremities (e.g., metal implants, prostheses)\n* Venous insufficiency Unilateral weakness in the lower extremity (e.g., after a stroke)\n* Known iodine allergy (contraindication for ICG injection)\n* Leg length discrepancy (anisomelia) \\> 1.5 cm",{"count":56,"type":20},66,[23],"This multicentre pragmatic randomised controlled trial evaluates lymphovenous anastomosis (LVA) for lower-limb lymphedema (LLL) in Denmark. Adults with unilateral or bilateral International Society of Lymphology (ISL) stage 1-2a LLL who have completed protocol-defined Complete Decongestive Therapy (CDT) are randomised 1:1 to\n\nIntervention arm - LVA surgery plus ongoing compression care\n\nControl arm - Compression care only\n\nRecruitment takes place at the Departments of Plastic Surgery, Herlev-Gentofte Hospital and Odense University Hospital. Outcomes are assessed by independent blinded staff at baseline, 6, 12 and 24 months. A biopsy substudy in ten LVA patients explores inflammatory and fibrotic changes. Primary endpoint is change in L-Dex ratio at 12 months. Secondary endpoints include limb volume, infection rate, lymphoscintigraphy findings, patient-reported outcomes, compression-garment use and anastomosis patency.\n\nThe trial follows Good Clinical Practice and General Data Protection Regulation (GDPR). Patients are covered by the Danish public patient-compensation scheme. Results will be published regardless of outcome, and control participants may opt for LVA after the 12-month visit.",[60,61,62,30],"Lymphedema","Lymphoedema","Lymphoedema of Leg",[64,35,65,66,67,68,69],"Lymphovenous Anastomosis","Lower Limb Lymphedema","Leg Lymphedema","Randomized Controlled Trial","CDT","Compression Therapy","2025-07-29",{"date":72,"type":40},"2025-07-31",{"date":74,"type":40},"2025-05-09",{"date":76,"type":20},"2029-08",{"name":78,"class":47},"Herlev and Gentofte Hospital",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100513791","hydrophobic-tubes-for-the-treament-of-lower-and-upper-limb-lymphedema-100513791","NCT05970068","Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema","Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial","Inclusion Criteria:\n\n* Lower limb lymphedema (Grade II-IV)\n* Total occlusion at lymphoscintigraphy\n* Patients treated at Centro Hospitalar Universitário de São João by the same surgical team\n* Age \\>18 years old;\n* Lymphedema praecox\n* Lower limb perimeter \\>15% superior to contralateral limb\n\nExclusion Criteria:\n\n* Secondary lymphedema\n* Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)\n* Acute infection of the limb\n* Chronic venous insufficiency\n* Neoplasic disease","70 Years",{"count":89,"type":20},20,[23],"Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.",[30],[60,94,95,96],"quality of life","edema","lower limb","NOT_YET_RECRUITING","2023-10-29",{"date":100,"type":40},"2023-11-01",{"date":102,"type":20},"2023-12-15",{"date":104,"type":20},"2026-12-31",{"name":106,"class":47},"Universidade do Porto",1]