Status:
ACTIVE_NOT_RECRUITING
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Breast Reconstruction
Implant-Based Breast Reconstruction (IBBR)
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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) com...
Detailed 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) com...
Eligibility Criteria
Inclusion
- 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
Exclusion
- No indication for IBBR according to clinical judgment of the treating surgeon
- Skin flaps inadequate for pre-pectoral IBBR.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2033
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT04293146
Start Date
July 28 2020
End Date
February 1 2033
Last Update
December 13 2024
Active Locations (22)
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1
Brigham and Women's Hospital Harvard Medical School
Boston, Massachusetts, United States, 02115
2
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Salzburg, Austria, 5020
3
Medizinische Universität Wien
Vienna, Austria, 1090
4
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie
Duisburg, Germany