[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513791":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":32,"responsibleParty":45,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Universidade do Porto","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Surgery + best medical treatment","EXPERIMENTAL","The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available.",[13,14],"Procedure: implantation of hydrophobic tubes for edema fluid drainage","Device: Best Medical Treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Group 2: best medical treatment","ACTIVE_COMPARATOR","This control group would receive only the best medical treatment available.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","implantation of hydrophobic tubes for edema fluid drainage","1 - A 2-cm-long incision is made at the border of the hypogastrium or lumbar region 10 cm above the inguinal crease; 2- A 1.5-cm-wide and 100-cm-long metal tube tunneling device is introduced under the skin and bluntly passed in the subcutaneous tissue toward the thigh and internal aspect of the calf; 3- Incisions 2 cm long are made in the groin and calf, through which the tunneling device was passed; 4-The hydrophobic tube is passed upward through the tunneling device, after which the tunneling device is removed; 5-The upper and lower ends of the hydrophobic tubes are fixed to the fascia with absorbable sutures.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Best Medical Treatment","Compressive therapy, Phisioterapy, venous intervention",[9,16],[33],{"facility":34,"status":26,"city":35,"state":26,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":26},"Faculdade de Medicina da Universidade do Porto","Porto","4200-319","Portugal","PT",{"type":40,"coordinates":41},"Point",[42,43],-8.61097,41.1485,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","João Rocha Neves","MD, MPH, PHD, FEBVS","100513791","hydrophobic-tubes-for-the-treament-of-lower-and-upper-limb-lymphedema-100513791",false,"NCT05970068","Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema","Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial","Inclusion Criteria:\n\n* Lower limb lymphedema (Grade II-IV)\n* Total occlusion at lymphoscintigraphy\n* Patients treated at Centro Hospitalar Universitário de São João by the same surgical team\n* Age \\>18 years old;\n* Lymphedema praecox\n* Lower limb perimeter \\>15% superior to contralateral limb\n\nExclusion Criteria:\n\n* Secondary lymphedema\n* Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)\n* Acute infection of the limb\n* Chronic venous insufficiency\n* Neoplasic disease","ALL","18 Years","70 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"NA","Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.",[67],"Lymphedema of Leg",[69,70,71,72],"Lymphedema","quality of life","edema","lower limb","NOT_YET_RECRUITING","2023-10-29",{"date":76,"type":77},"2023-11-01","ACTUAL",{"date":79,"type":61},"2023-12-15",{"date":81,"type":61},"2026-12-31",{"name":5,"class":6},1]