[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444188":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":40,"locations":49,"responsibleParty":96,"collaborators":25,"id":98,"slug":25,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":25,"enrollmentInfo":107,"targetDuration":25,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":52,"whyStopped":25,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Reconstructive lymphatic surgery","EXPERIMENTAL","The intervention treatment is reconstructive lymphatic surgery and consists of the application of lymphovenous anastomosis (LVA), lymph node transfer (LNT) or a combination of both. The choice of reconstructive technique(s) is determined by the surgeon and is based on the algorithm for reconstructive lymphatic surgery of lymphoedema.\n\nAdditionally, all patients receive usual care (i.e. maintenance decongestive lymphatic therapy)",[13,14],"Other: Usual care","Procedure: Reconstructive lymphatic surgery",{"label":16,"type":17,"description":18,"interventionNames":19},"No surgery","ACTIVE_COMPARATOR","All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)",[13],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Usual care","Home physical therapist performs usual care and educates the patient to perform self-management\n\nUsual care:\n\nM1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist):\n\n* week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)\u002F compression garment (control group)\n* week 3-4: start physical therapy, 2 days\u002F week: exercises, skin care \\& manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h\u002Fday (4 sessions) M2-6: 1 day\u002F week physical therapist: exercises, skin care \\& MLD, and self-management by patient and wearing compression garment 14-16h\u002Fday (20 sessions)\n\nM7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist:\n\n\\- 1 day\u002Fweek physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up",[16,9],null,{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":25},"PROCEDURE","For the procedure of LVA:\n\n\\- Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly\n\nFor the procedure of LNT:\n\n\\- Aim:\n\n1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network;\n2. Placed lymph nodes induce lymphangiogenesis",[9],[31,34,37],{"name":32,"affiliation":5,"role":33},"Nele Devoogdt","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Thierry Deltombe","CHU-UCL Mont-Godinne",{"name":38,"affiliation":39,"role":33},"Caren Randon","University Hospital, Ghent",[41,45],{"name":32,"role":42,"phone":43,"phoneExt":25,"email":44},"CONTACT","0032 16 34 25 15","nele.devoogdt@kuleuven.be",{"name":46,"role":42,"phone":47,"phoneExt":25,"email":48},"Tessa De Vrieze","0032 16 34 50 06","tessa.devrieze@kuleuven.be",[50,67,83],{"facility":51,"status":52,"city":53,"state":25,"zip":25,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ghent University Hospital","RECRUITING","Ghent","Belgium",{"type":56,"coordinates":57},"Point",[58,59],3.71667,51.05,{"lat":59,"lon":58},[62,65],{"name":63,"role":42,"phone":25,"phoneExt":25,"email":64},"Caren Randon, PhD","Caren.randon@uzgent.be",{"name":25,"role":42,"phone":66,"phoneExt":25,"email":25},"0032 9 332 34 49",{"facility":68,"status":52,"city":69,"state":25,"zip":70,"country":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University Hospitals of Leuven, center for lymphedema","Leuven","3000",{"type":56,"coordinates":72},[73,74],4.70093,50.87959,{"lat":74,"lon":73},[77,81],{"name":78,"role":42,"phone":79,"phoneExt":25,"email":80},"Nele Devoogdt, PhD","0032 16 342515","nele.devoogdt@uzleuven.be",{"name":82,"role":42,"phone":47,"phoneExt":25,"email":48},"Tessa De Vrieze, PhD",{"facility":36,"status":52,"city":84,"state":25,"zip":25,"country":54,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Namur",{"type":56,"coordinates":86},[87,88],4.86746,50.4669,{"lat":88,"lon":87},[91,94],{"name":92,"role":42,"phone":25,"phoneExt":25,"email":93},"Thierry Deltombe, PhD","Thierry.deltombe@uclouvain.be",{"name":25,"role":42,"phone":95,"phoneExt":25,"email":25},"0032 81 42 37 72",{"type":97,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100444188",false,"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","ALL","18 Years",{"count":108,"type":109},180,"ESTIMATED","INTERVENTIONAL",[112],"NA","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?'",[115,116,117],"Lymphoedema of Leg","Lymphedema Arm","Lymphedema",[9,119,120,121],"Decongestive lymphatic therapy","Lymphovenous anastomosis","Lymph node transfer","2024-07-01",{"date":124,"type":125},"2024-07-03","ACTUAL",{"date":127,"type":125},"2022-02-01",{"date":129,"type":109},"2026-12",{"name":5,"class":6},3]