[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610921":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":56,"collaborators":18,"id":59,"slug":18,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Dharmais National Cancer Center Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lymphovenous bypass (LVB)","EXPERIMENTAL","Sixty-eight subjects will be needed per group. LVB was performed by creating an intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient veins. After surgery, follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.",[13],"Procedure: Lymphovenous bypass (LVB)",{"label":15,"type":16,"description":17,"interventionNames":18},"Physiotherapy","NO_INTERVENTION","Sixty-eight subjects will be needed per group. Patients will receive physiotherapy from trained physiotherapists. The protocol includes manual lymphatic drainage (massage techniques), compression, skin care, and arm exercises. Follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","The Lymphovenous Bypass (LVB) procedure in this study is a microsurgical supermicrosurgery-based intervention specifically designed for the secondary prevention of breast cancer-related lymphedema following axillary lymph node dissection.",[9],[25],{"name":26,"affiliation":27,"role":28},"Bayu Brahma, MD, PhD","Dharmais Cancer Hospital - National Cancer Center","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Adhitya B Perdana, MEpi","CONTACT","+62 85692445029","adhityabayu@dharmais.co.id",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Dharmais National Cancer Center","RECRUITING","Jakarta","Jakarta Special Capital Region","11420","Indonesia","ID",{"type":45,"coordinates":46},"Point",[47,48],106.84513,-6.21462,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":54,"email":55},"Natarini Setianingsih","+62 5681570","2372","dharmais@dharmais.co.id",{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Bayu Brahma","MD, PhD","100610921",false,"NCT07233863","Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer","Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer","Inclusion Criteria:\n\n* Breast cancer patients aged ≥ 18 years with an ECOG score \\> 1\n* Breast cancer patients with post-axillary lymph node dissection diagnosed with stage 0 and I lymphedema.\n* Those who have never undergone lymphedema physiotherapy.\n\nExclusion Criteria:\n\n* Patients with dermal backflow before axillary lymph node dissection (ALND).\n* Patients with breast cancer lymphedema who are unable to undergo a 24-month follow-up at Dharmais Cancer Hospital.\n* Patients with iodine allergy, severe asthma, decreased kidney function, pregnancy, or breastfeeding.","ALL","18 Years",{"count":68,"type":69},136,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study aims to evaluate the effectiveness of the Lymphovenous Bypass (LVB) procedure compared to physiotherapy alone as secondary prevention of lymphedema in breast cancer patients undergoing axillary lymph node dissection.",[75],"Lymphedema Arm",[77,78],"Breast Cancer","Lymphedema","2025-11-14",{"date":81,"type":82},"2025-11-18","ACTUAL",{"date":84,"type":82},"2024-03-18",{"date":86,"type":69},"2028-03-21",{"name":5,"class":6},1]