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Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
Sponsor: University Hospital, Basel, Switzerland
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.
Official title: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): a Pragmatic, Multicenter, Randomized, Superiority Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
382
Start Date
2020-07-28
Completion Date
2033-02
Last Updated
2024-12-13
Healthy Volunteers
No
Interventions
pre-pectoral IBBR
The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.
sub-pectoral IBBR
The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.
Locations (22)
Brigham and Women's Hospital Harvard Medical School
Boston, Massachusetts, United States
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Salzburg, Austria
Medizinische Universität Wien
Vienna, Austria
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie
Duisburg, Germany
KEM | Evang. Kliniken Essen-Mitte
Essen, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Landesfrauenklinik, Senologie und Brustzentrum
Wuppertal, Germany
National Institute of Oncology
Budapest, Hungary
Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica
Roma, Italy
Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center
Trento, Italy
Capio S:t Görans Hospital
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Klinik Hirslanden Brustzentrum Aarau
Aarau, Switzerland
Kantonsspital Aarau AG
Aarau, Switzerland
University Hospital Basel, Division of Breast Surgery
Basel, Switzerland
Universitätsklinik für Plastische- und Handchirurgie, Inselspital
Bern, Switzerland
Lindenhof Bern
Bern, Switzerland
Kantonsspital Frauenfeld
Frauenfeld, Switzerland
Gesundheitszentrum Fricktal
Rheinfelden, Switzerland
Ospedale Regionale di Lugano
Viganello, Switzerland
Brust-Zentrum Zürich
Zurich, Switzerland