[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598599":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":77,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Lymphovenous anastomosis (LVA) + Compression Therapy","EXPERIMENTAL","LVA + conservative care. Patient must have undergone Complete Decongestive Therapy (CDT) and comply with the compression treatment. Follow-up at 6, 12 and 24 months includes blinded assessment of L-Dex, tape and perometry volumes, DXA, lymphoscintigraphy, erysipelas incidence and LYMQOL\u002FEQ-5D-5L scores; patency is checked by ICG-lymphography at 12 months. A subset of 10 patients with unilateral lymphedema also provides paired skin biopsies (both legs) at surgery and again 6 months postoperatively for biomarker and histological analysis.",[13,14],"Procedure: Lymphovenous Anastomosis","Other: Complete Decongestive Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Compression Therapy Alone","ACTIVE_COMPARATOR","Conservative care alone. Participants complete standard Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments. Outcomes are assessed by the same blinded schedule as the LVA arm at baseline, 6, 12 and 24 months. Participants may elect LVA crossover after the 12-month evaluation if desired.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Lymphovenous Anastomosis","Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Complete Decongestive Therapy","Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.",[16,9],[32],"CDT",[34],{"name":35,"affiliation":36,"role":37},"Lisbet Rosenkrantz Hölmich, MD, Professor, DMSc","Department of Plastic Surgery, Herlev and Gentofte Hospital, Denmark","STUDY_CHAIR",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Amar Bucan, Medical doctor","CONTACT","+4538685444","amar.bucan.02@regionh.dk",[45,64],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Department of Plastic Surgery, Odense University Hospital","NOT_YET_RECRUITING","Odense","Fyn","5","Denmark","DK",{"type":54,"coordinates":55},"Point",[56,57],10.38831,55.39594,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":26,"email":63},"Jørn Bo Thomsen, MD, PhD","+45 65 41 24 45","joern.bo.thomsen@rsyd.dk",{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":51,"countryCode":52,"cosmosGeoPoint":26,"geoPoint":26,"contacts":70},"Department of Plastic Surgery, Herlev and Gentofte Hospital","RECRUITING","Herlev","Region Sjælland","2730",[71,73,75],{"name":40,"role":41,"phone":72,"phoneExt":26,"email":43},"+4538689045",{"name":35,"role":41,"phone":72,"phoneExt":26,"email":74},"lisbet.rosenkrantz.hoelmich@regionh.dk",{"name":40,"role":76,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":76,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Amar Bucan","Medical doctor","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":90,"type":91},66,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98,99,100],"Lymphedema","Lymphoedema","Lymphoedema of Leg","Lymphedema of Leg",[23,102,103,104,105,32,106],"LVA","Lower Limb Lymphedema","Leg Lymphedema","Randomized Controlled Trial","Compression Therapy","2025-07-29",{"date":109,"type":110},"2025-07-31","ACTUAL",{"date":112,"type":110},"2025-05-09",{"date":114,"type":91},"2029-08",{"name":5,"class":6},2]