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Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC Summary This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer .
View Full Description Full Description This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.
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There are 20 Locations for this study
Brigham and Women's Hospital Harvard Medical School Boston Massachusetts, 02115, United States
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Universitätsklinik für Frauenheilkunde und Geburtshilfe Salzburg , 5020, Austria
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Medizinische Universität Wien Wien , 1090, Austria
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Ruijin Hospital Shanghai , 20002, China
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Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie Duisburg , , Germany
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KEM | Evang. Kliniken Essen-Mitte Essen , 45136, Germany
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Universitätsklinikum Heidelberg Heidelberg , 69120, Germany
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Landesfrauenklinik, Senologie und Brustzentrum Wuppertal , , Germany
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National Institute of Oncology Budapest , 1122, Hungary
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Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica Roma , , Italy
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Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center Trento , , Italy
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Capio S:t Görans Hospital Stockholm , 11281, Sweden
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Södersjukhuset Stockholm , 11281, Sweden
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Karolinska University Hospital Stockholm , 17176, Sweden
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Klinik Hirslanden Brustzentrum Aarau Aarau , 5000, Switzerland
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Kantonsspital Aarau AG Aarau , 5001, Switzerland
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University Hospital Basel, Division of Breast Surgery Basel , 4031, Switzerland
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Universitätsklinik für Plastische- und Handchirurgie, Inselspital Bern , 3010, Switzerland
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Lindenhof Bern Bern , 3011, Switzerland
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Kantonsspital Frauenfeld Frauenfeld , 8501, Switzerland
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Hirslanden Klinik St. Anna
Gesundheitszentrum Fricktal Rheinfelden , 4310, Switzerland
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Kantonsspital St.Gallen
Ospedale Regionale di Lugano Viganello , 6962, Switzerland
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Brust-Zentrum Zürich Zürich , 8008, Switzerland
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