Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
Running, not enrolling · Not applicable
Conditions studied: Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR)
In brief
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.
Key facts
- Study ID
- NCT04293146
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 382
- Starts
- 2020-07-28
- Expected to finish
- 2033-02-01
- Last updated by the study team
- 2024-12-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
- Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
- Ability to complete the Quality of Life questionnaires
You may not qualify if…
- No indication for IBBR according to clinical judgment of the treating surgeon
- Skin flaps inadequate for pre-pectoral IBBR.
Where it is running
- 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
Full record on ClinicalTrials.gov
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