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ACTIVE NOT RECRUITING
NCT04293146
NA

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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

PROCEDURE

pre-pectoral IBBR

The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.

PROCEDURE

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