[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoedema-of-leg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoedema-of-leg":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100598599","effect-of-lymphovenous-anastomosis-on-lower-limb-lymphedema-pragmatic-randomized-controlled-trial-100598599",false,"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","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28,29],"Lymphedema","Lymphoedema","Lymphoedema of Leg","Lymphedema of Leg",[31,32,33,34,35,36,37],"Lymphovenous Anastomosis","LVA","Lower Limb Lymphedema","Leg Lymphedema","Randomized Controlled Trial","CDT","Compression Therapy","RECRUITING","2025-07-29",{"date":41,"type":42},"2025-07-31","ACTUAL",{"date":44,"type":42},"2025-05-09",{"date":46,"type":20},"2029-08",{"name":48,"class":49},"Herlev and Gentofte Hospital","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100444188","added-value-of-reconstructive-lymphatic-surgery-to-usual-care-in-lymphoedema-100444188","NCT05064176","Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema","Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled Trial","SurLym","Inclusion Criteria:\n\n* Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb\n* If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if:\n\n  * estimated cancer-related survival is ≥3 years\n  * oncological safety is guaranteed: for instance, time interval since radiotherapy\u002F chemotherapy is ≥3 months\n* Lymphoedema stage 1 to 2b\n* Objective diagnosis of lymphoedema: ≥ 5% volume difference OR ≥ 2 minor\u002F 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow\n* Score on Lymph-ICF questionnaire at screening: ≥ 25 \u002F 100 (= moderate level of problems in functioning related to the development of lymphoedema)\n* History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Participants with history of liposuction, lymphovenous anastomosis, lymph node transfer\n* Pregnant participants\n* Severe obese participants: BMI\\>35\n* Estimated cancer-related survival is \\\u003C3 years and oncological safety is not guaranteed (e.g. interval since radiotherapy\u002F chemotherapy is \\\u003C3 months)\n* In case of lower limb lymphoedema: presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome\n* Allergy for ICG, iodine, penicillin and sulphonamides; increased activity of thyroid gland; benign tumour in thyroid; heparin use and severe renal insufficiency",{"count":59,"type":20},180,[23],"The primary objective of this research proposal is to investigate\n\n* in patients with lymphoedema of the upper limb or lower limb (P)\n* the added value of reconstructive lymphatic surgery (I)\n* to the decongestive lymphatic therapy (usual care) (C)\n* on the lymphoedema-specific quality of life (QoL) (O)\n* at 18 months post-surgery\u002F no surgery (T)\n\nConsequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'",[28,63,26],"Lymphedema Arm",[65,66,67,68],"Reconstructive lymphatic surgery","Decongestive lymphatic therapy","Lymphovenous anastomosis","Lymph node transfer","2024-07-01",{"date":71,"type":42},"2024-07-03",{"date":73,"type":42},"2022-02-01",{"date":75,"type":20},"2026-12",{"name":77,"class":49},"Universitaire Ziekenhuizen KU Leuven",3]