[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lower-limb-lymphedema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lower-limb-lymphedema":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,76,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100462334","lymphoedema-and-nocturianocturnal-polyuria-after-pelvic-lnd-for-urogenital-cancer-100462334",false,"NCT05300308","Lymphoedema and Nocturia\u002FNocturnal Polyuria After Pelvic LND for Urogenital Cancer","Lymphoedema and Nocturia\u002F Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study","UroLymph","Inclusion Criteria:\n\n* Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)\n* Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection\n* Salvage lymph node dissection\n* Before inclusion, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Radiological evidence of metastatic disease based on pelvic CT\u002FMRI and bone scan\n* Clinical signs of chronic venous insufficiency (CEAP C3-C6)\n* History of lymph node dissection\u002F radiotherapy at the level of the pelvis or groin","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and\u002F or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence\u002F prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated.\n\nAdditionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).",[25,26,27,28],"Urogenital Cancer","Lower Limb Lymphedema","Nocturia","Nocturnal Polyuria","RECRUITING","2025-07-08",{"date":32,"type":33},"2025-07-11","ACTUAL",{"date":35,"type":33},"2022-01-21",{"date":37,"type":21},"2026-11",{"name":39,"class":40},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},"100580637","effects-of-hydrotherapy-on-unilateral-lower-extremity-lymphedema-100580637","NCT06839885","Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema","Evaluation of the Effects of Hydrotherapy on Lower Extremity Volume, Quality of Life, and Functionality in Patients Diagnosed With Unilateral Lower Extremity Lymphedema","Inclusion Criteria:\n\n* Patients with primary or secondary unilateral lower extremity lymphedema diagnosis\n* Patients who have received at least 2 weeks of complex decongestive therapy in the past\n* Patients who are cooperative with hydrotherapy treatments\n* Patients who are willing to participate in the treatment\n* Patients aged 18-75\n\nExclusion Criteria:\n\n* Patients who are unable to perform the evaluation parameters\n* Patients with serious systemic diseases that may prevent exercise\n* Patients who have had an injury and\u002For surgery in the last 6 months\n* Conditions where hydrotherapy is contraindicated (severe fear of water, behavioral problems, shortness of breath at rest, incontinence, known chlorine allergy, open wound, acute systemic illness, epilepsy, tracheostomy, permanent drain, immunodeficiency)\n* Patients with an active infection anywhere in the body\n* Patients who have undergone sentinel lymph node biopsy\n* Patients with active metastatic disease","75 Years",{"count":51,"type":21},52,"INTERVENTIONAL",[54],"NA","Lymphedema is a chronic condition that negatively affects patients' quality of life and lower extremity functions, causing swelling and a feeling of heaviness in the extremity, as well as posing an economic burden. The gold standard in lymphedema treatment is complex decongestive therapy.Manual lymphatic drainage, skin care, the use of compression garments, and home exercise programs play an important role. Exercise therapies lead to a reduction in volume and an improvement in functionality and quality of life in patients with lymphedema. However, studies on this subject have mostly focused on upper extremity lymphedema. This study aims to compare the effects of a home exercise program and hydrotherapy combined with a home exercise program on quality of life, lower extremity functionality, exercise capacity, and edema severity in patients with unilateral lower extremity lymphedema",[26,57],"Unilateral Leg Edema",[59,60,61,62,63,64,65],"Aerobic exercise","Hydrotherapy","Functionality","Gynecological cancer","Lymphedema","Exercise capacity","Quality of life","2025-02-17",{"date":68,"type":33},"2025-02-21",{"date":70,"type":33},"2024-12-15",{"date":72,"type":21},"2025-12-15",{"name":74,"class":75},"Gaziosmanpasa Research and Education Hospital","OTHER_GOV",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100519078","development-of-a-clinical-screening-diagnostic-and-evaluation-tool-for-patients-with-lower-limb-lymphedema-aim-4-100519078","NCT06038864","Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4","Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of an Evaluation Set for Patients With LLL","EvaLymph-Leg4","Inclusion Criteria:\n\n* Intensive treatment group\n\n  * Unilateral or bilateral, primary or secondary LLL\n  * No active metastases\n  * If cancer-related lymphedema, time interval since surgery\u002F radiotherapy\u002F chemotherapy is ≥3 months\n  * Objective diagnosis of lymphedema: ≥ 5% volume difference OR ≥ 2 minor\u002F 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow\n  * Age ≥ 18 years\n  * Able to read, understand and speak Dutch\n  * Planned to start with intensive decongestive lymphatic therapy at one or both legs\n* Maintenance treatment group\n\n  * See inclusion criteria 'intensive treatment group'\n  * But: instead of patients planned to start with intensive lymphatic therapy, patients of this group should have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)\n\nExclusion Criteria:\n\n* Pregnant participants\n* Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome\n* Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion",{"count":85,"type":21},120,"Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation.\n\nTo assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects.\n\nFirst of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high.\n\nTherefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?",[26],[89,90,91],"lymphedema","measurement","clinical evaluation","2024-09-06",{"date":94,"type":33},"2024-09-19",{"date":96,"type":33},"2024-04-01",{"date":98,"type":21},"2025-12-01",{"name":100,"class":40},"KU Leuven",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":41},"100459949","development-of-a-clinical-screening-diagnostic-and-evaluation-tool-for-patients-with-lower-limb-lymphedema-aim-1-100459949","NCT05269264","Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1","Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema (LLL): Reliability, Concurrent Validity and Clinical Feasibility of Currently Applied Measurement Tools in Patients With LLL","EvaLymph-Leg1","Inclusion Criteria:\n\nPatient group\n\n* Unilateral or bilateral, primary or secondary Lower limb lymphedema (LLL)\n* Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor\u002F 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow\n* Age ≥ 18 years\n* Able to read, understand and speak Dutch\n\nHealthy controls\n\n\\- Age, gender \\& BMI-matched healthy controls\n\nExclusion Criteria:\n\n* Pregnant participants\n* Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome\n* Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion",true,{"count":112,"type":21},200,"Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL).\n\nThe objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.",[26],[63,116,117,118,119,120,121],"Measurement","Clinical evaluation","Reliability","Concurrent validity","Clinical feasibility","Lower limb","2024-07-01",{"date":124,"type":33},"2024-07-03",{"date":126,"type":33},"2022-02-07",{"date":128,"type":21},"2025-10",{"name":39,"class":40}]