Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

  • STATUS
    Recruiting
  • End date
    Mar 29, 2033
  • participants needed
    372
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 19 February 2024
cancer
breast cancer
mastectomy
breast reconstruction

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.

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.

Details
Condition Mammoplasty, Implant-Based Breast Reconstruction (IBBR)
Age 18years - 100years
Treatment pre-pectoral IBBR, sub-pectoral IBBR
Clinical Study IdentifierNCT04293146
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

No indication for IBBR according to clinical judgment of the treating surgeon
Skin flaps inadequate for pre-pectoral IBBR
Clear my responses

How to participate?

Step 1 Connect with a study center
Entire World
Results (21 sites found)
  • 1

    Brigham and Women's Hospital Harvard Medical School

    Boston MA United States

  • 2

    Universit tsklinik f r Frauenheilkunde und Geburtshilfe

    Austria

  • 3

    Medizinische Universit t Wien

    Austria

  • 4

    Ruijin Hospital

    China

  • 5

    KEM | Evang. Kliniken Essen-Mitte

    Germany

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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