[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639113":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":23,"interventions":18,"overallOfficials":18,"centralContacts":30,"locations":18,"responsibleParty":37,"collaborators":41,"id":45,"slug":18,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":18,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":18},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Primary objective","To evaluate the rate of implant loss within 3 months per patient","3 months post-surgery",[14],{"measure":15,"description":16,"timeFrame":17},"Secondary objectives","To evalueate early and late-onset postoperative complications and to revaluate re-admission and re-operation rates","3, 12, 24 months post-surgery",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","RETROSPECTIVE","Data from breast cancer patients who completed pre-pectoral implant-based breast reconstruction, both DTI and TE-I, between January 2022 and December 2024, will be retrospectively extracted from electronic medical records and institutional databases.",[24,27],{"label":25,"type":18,"description":26,"interventionNames":18},"One-stage DTI","Patients who underwent one-stage direct-to-implant pre-pectoral reconstructive strategy",{"label":28,"type":18,"description":29,"interventionNames":18},"Two-stage TE-I","Patients who underwent two-stage expander-implant pre-pectoral reconstructive strategy",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Rosa Di Micco, MD, PhD","CONTACT","+39 022643","4565","dimicco.rosa@hsr.it",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Rosa Di Micco, MD","MD, PhD",[42],{"name":43,"class":44},"Regional Hospital Lugano (EOC), Switzerland","UNKNOWN","100639113",false,"NCT07593651","EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes","EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes : the EXPRESsO Study","EXPRESSO","Inclusion Criteria:\n\n* Female patients ≥18 years\n* Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer\n* Patients undergoing pre-pectoral implant-based breast reconstruction, either:\n\n  * One-stage DTI, or\n  * Two-stage TE-I\n* Use of implant with or without biological or synthetic mesh\n* Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side\n\nExclusion Criteria:\n\n* Male patients\n* Subpectoral implant-based reconstruction\n* Autologous breast reconstruction\n* Delayed reconstructions not performed at the time of mastectomy\n* Incomplete clinical or follow-up data for primary endpoint analysis","FEMALE","18 Years",{"count":55,"type":56},276,"ESTIMATED","OBSERVATIONAL","Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction. Within this reconstructive paradigm, surgeons may employ two distinct strategies:\n\n(i) immediate reconstruction using a direct-to-implant approach (DTI), or (ii) a two-stage reconstruction consisting of tissue expander placement followed by definitive implant insertion (TE-I).\n\nEach approach is associated with specific indications, advantages, and inherent limitations.\n\nThe EXPRESSO study aims to retrospectively compare surgical outcomes between pre-pectoral DTI and TE-I breast reconstruction. By providing real-world evidence on these reconstructive strategies, this study seeks to inform surgical decision-making and to optimize reconstructive outcomes in contemporary breast cancer care.",[60,61],"Breast Cancer","Operable Breast Cancer",[63,64,65],"breast cancer","Mastectomy","Pre-pectoral reconstruction","NOT_YET_RECRUITING","2026-05-11",{"date":69,"type":70},"2026-05-18","ACTUAL",{"date":72,"type":56},"2026-06",{"date":74,"type":56},"2027-12",{"name":5,"class":6}]