[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502047":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":31,"interventions":37,"overallOfficials":42,"centralContacts":47,"locations":57,"responsibleParty":217,"collaborators":221,"id":225,"slug":226,"hasResults":227,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":227,"sex":232,"minAge":233,"maxAge":31,"enrollmentInfo":234,"targetDuration":31,"studyType":237,"phases":31,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"European Breast Cancer Research Association of Surgical Trialists","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Number of patients with Implant-loss at three months postoperatively","Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication","three months postoperatively",[14,17,20,24,27],{"measure":15,"description":16,"timeFrame":12},"Number of patients with Infection","Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and\u002For hospitalisation was necessary;",{"measure":18,"description":19,"timeFrame":12},"Number of patients with re-admission and re-operation","Rate of re-admission and re-operation",{"measure":21,"description":22,"timeFrame":23},"Evaluation of Quality of life","Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)","0, 6, 12 and 24 months",{"measure":25,"description":26,"timeFrame":12},"Number of Early onset complication","Early onset complication at 3 month follow up: seroma, hematoma\u002Fbleeding, skin flap or T junction necrosis, nipple necrosis, wound dehiscence, implant malposition (i.e. rotation, displacement etc..), red-breast syndrome",{"measure":28,"description":29,"timeFrame":30},"Number of late-onset complications","seroma, capsular contracture, wrinkling\u002Frippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;","6-12-24 months",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.","All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient.\n\nThe therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.",[38],{"type":39,"name":40,"description":41,"armGroupLabels":31,"otherNames":31},"PROCEDURE","pre-pectoral breast reconstruction","to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy",[43],{"name":44,"affiliation":45,"role":46},"Oreste D Gentilini, Dr","IRCCS San Raffaele","STUDY_CHAIR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","+390226431","3939","gentilini@eubreast.com",{"name":54,"role":49,"phone":50,"phoneExt":55,"email":56},"Rosa Di Micco, Dr","4565","dimicco.rosa@hsr.it",[58,73,86,94,107,140,153,166,179,192,204],{"facility":59,"status":60,"city":61,"state":31,"zip":31,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Univesidad de Buenos Aires","RECRUITING","Buenos Aires","Argentina","AR",{"type":65,"coordinates":66},"Point",[67,68],-58.37723,-34.61315,{"lat":68,"lon":67},[71],{"name":72,"role":49,"phone":31,"phoneExt":31,"email":31},"Eduardo Gonzalez, MD",{"facility":74,"status":60,"city":75,"state":31,"zip":31,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Mansoura Insurance","Al Mansurah","Egypt","EG",{"type":65,"coordinates":79},[80,81],31.38069,31.03637,{"lat":81,"lon":80},[84],{"name":85,"role":49,"phone":31,"phoneExt":31,"email":31},"Khaled Ali",{"facility":87,"status":60,"city":75,"state":31,"zip":31,"country":76,"countryCode":77,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Mansoura Oncology",{"type":65,"coordinates":89},[80,81],{"lat":81,"lon":80},[92],{"name":93,"role":49,"phone":31,"phoneExt":31,"email":31},"Khaled Ali, MD",{"facility":95,"status":60,"city":96,"state":31,"zip":31,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"National ans Kapodistrian University of Athens","Athens","Greece","GR",{"type":65,"coordinates":100},[101,102],23.72784,37.98376,{"lat":102,"lon":101},[105],{"name":106,"role":49,"phone":31,"phoneExt":31,"email":31},"Michalis Kontos, MD",{"facility":108,"status":60,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Ospedale San Raffaele","Milan","MI","20132","Italy","IT",{"type":65,"coordinates":115},[116,117],12.59836,42.78235,{"lat":117,"lon":116},[120,123,126,128,130,132,134,136,138],{"name":121,"role":49,"phone":31,"phoneExt":31,"email":122},"ORESTE DAVIDE GENTILINI, MD","gentilini.oreste@hsr.it",{"name":124,"role":125,"phone":31,"phoneExt":31,"email":31},"ROSA DI MICCO","SUB_INVESTIGATOR",{"name":127,"role":125,"phone":31,"phoneExt":31,"email":31},"LUIGI GIANOLLI",{"name":129,"role":125,"phone":31,"phoneExt":31,"email":31},"CARLA CANEVARI",{"name":131,"role":125,"phone":31,"phoneExt":31,"email":31},"PIETRO PANIZZA",{"name":133,"role":125,"phone":31,"phoneExt":31,"email":31},"CLAUDIO LOSIO",{"name":135,"role":125,"phone":31,"phoneExt":31,"email":31},"ELENA VENTURINI",{"name":137,"role":125,"phone":31,"phoneExt":31,"email":31},"ZUBER VERONICA",{"name":139,"role":125,"phone":31,"phoneExt":31,"email":31},"ANNARITA SAVI",{"facility":141,"status":60,"city":142,"state":143,"zip":144,"country":112,"countryCode":113,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Fondazione Policlinico Universitario Agostino Gemelli","Roma","RM","00136",{"type":65,"coordinates":146},[147,148],11.10642,44.99364,{"lat":148,"lon":147},[151],{"name":152,"role":49,"phone":31,"phoneExt":31,"email":31},"Gianluca Franceschini, MD",{"facility":154,"status":60,"city":155,"state":31,"zip":31,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University Hospital of Karol Marcinkowski","Zielona Góra","Poland","PL",{"type":65,"coordinates":159},[160,161],15.50643,51.93548,{"lat":161,"lon":160},[164],{"name":165,"role":49,"phone":31,"phoneExt":31,"email":31},"Dawid Murawa",{"facility":167,"status":60,"city":168,"state":31,"zip":31,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Prof. Dr. Ion Chiricuta Institute of Oncology","Cluj-Napoca","Romania","RO",{"type":65,"coordinates":172},[173,174],23.6,46.76667,{"lat":174,"lon":173},[177],{"name":178,"role":49,"phone":31,"phoneExt":31,"email":31},"Maximilian Muntean, MD",{"facility":180,"status":60,"city":181,"state":31,"zip":31,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Hospital del Mar","Barcelona","Spain","ES",{"type":65,"coordinates":185},[186,187],2.15899,41.38879,{"lat":187,"lon":186},[190],{"name":191,"role":49,"phone":31,"phoneExt":31,"email":31},"Maria Del Mar Bernet-Tomas, MD",{"facility":193,"status":60,"city":194,"state":31,"zip":31,"country":195,"countryCode":31,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Marmara University School of medicine","Istanbul","Turkey (Türkiye)",{"type":65,"coordinates":197},[198,199],28.94966,41.01384,{"lat":199,"lon":198},[202],{"name":203,"role":49,"phone":31,"phoneExt":31,"email":31},"Umit Ugurlu, MD",{"facility":205,"status":60,"city":206,"state":31,"zip":31,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"University Hospitals of Leicester","Leicester","United Kingdom","UK",{"type":65,"coordinates":210},[211,212],-1.13169,52.6386,{"lat":212,"lon":211},[215],{"name":216,"role":49,"phone":31,"phoneExt":31,"email":31},"Tim Rattay",{"type":218,"investigatorFullName":219,"investigatorTitle":220,"investigatorAffiliation":45,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Oreste Davide Gentilini","Professor, Head of Breast Surgery Unit",[222],{"name":223,"class":224},"EUBREAST ETS","UNKNOWN","100502047","international-prospective-registry-on-pre-pectoral-breast-reconstruction-100502047",false,"NCT05817175","International Prospective REgistry on Pre-pectorAl Breast REconstruction","I-PREPARE","Inclusion Criteria:\n\n* Female patients older than 18 years old\n* Signed informed consent form\n* Patients undergoing mono or bilateral therapeutic mastectomy\n* Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh\n\nExclusion Criteria:\n\n* Male patients\n* Patients not suitable for surgical treatment\n* Patients undergoing subpectoral reconstruction\n* Patients undergoing breast reconstruction with autologous tissue.","FEMALE","18 Years",{"count":235,"type":236},1236,"ESTIMATED","OBSERVATIONAL","This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.",[240],"Breast Cancer",[240,242,243,244],"Breast reconstruction","Pre-pectoral Breast Prosthesis","Mastectomy","2026-09-09",{"date":247,"type":248},"2026-09-11","ACTUAL",{"date":250,"type":248},"2023-09-12",{"date":252,"type":236},"2029-06-10",{"name":5,"class":6},11]