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

NCT ID: NCT04293146

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2033-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Reconstruction Implant-Based Breast Reconstruction (IBBR)

Keywords

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skin-sparing mastectomy (SSM) nipple-sparing mastectomy (NSM) immediate breast reconstruction pre-pectoral breast implant sub-pectoral breast implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will objectively assess the results and complication of two surgical techniques and thus provide evidence to assess whether there are differences between these techniques.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
blinded outcome assessment for aesthetic results

Study Groups

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pre-pectoral IBBR

Group Type ACTIVE_COMPARATOR

pre-pectoral IBBR

Intervention Type PROCEDURE

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

sub-pectoral IBBR

Group Type ACTIVE_COMPARATOR

sub-pectoral IBBR

Intervention Type PROCEDURE

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

Interventions

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pre-pectoral IBBR

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

Intervention Type PROCEDURE

sub-pectoral IBBR

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Weber, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Division of Breast Surgery, University Hospital Basel

Locations

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Brigham and Women's Hospital Harvard Medical School

Boston, Massachusetts, United States

Site Status

Universitätsklinik für Frauenheilkunde und Geburtshilfe

Salzburg, , Austria

Site Status

Medizinische Universität Wien

Vienna, , Austria

Site Status

Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie

Duisburg, , Germany

Site Status

KEM | Evang. Kliniken Essen-Mitte

Essen, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Landesfrauenklinik, Senologie und Brustzentrum

Wuppertal, , Germany

Site Status

National Institute of Oncology

Budapest, , Hungary

Site Status

Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica

Roma, , Italy

Site Status

Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center

Trento, , Italy

Site Status

Capio S:t Görans Hospital

Stockholm, , Sweden

Site Status

Södersjukhuset

Stockholm, , Sweden

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Klinik Hirslanden Brustzentrum Aarau

Aarau, , Switzerland

Site Status

Kantonsspital Aarau AG

Aarau, , Switzerland

Site Status

University Hospital Basel, Division of Breast Surgery

Basel, , Switzerland

Site Status

Universitätsklinik für Plastische- und Handchirurgie, Inselspital

Bern, , Switzerland

Site Status

Lindenhof Bern

Bern, , Switzerland

Site Status

Kantonsspital Frauenfeld

Frauenfeld, , Switzerland

Site Status

Gesundheitszentrum Fricktal

Rheinfelden, , Switzerland

Site Status

Ospedale Regionale di Lugano

Viganello, , Switzerland

Site Status

Brust-Zentrum Zürich

Zurich, , Switzerland

Site Status

Countries

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China United States Austria Germany Hungary Italy Sweden Switzerland

References

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Kappos EA, Schulz A, Regan MM, Moffa G, Harder Y, Ribi K, Potter S, Pusic AL, Fehr MK, Hemkens LG, Holzbach T, Farhadi J, Simonson C, Knauer M, Verstappen R, Bucher HC, Zwahlen D, Zimmermann F, Schwenkglenks M, Mucklow R, Shaw J, Bjelic-Radisic V, Chiorescu A, Chun YS, Farah S, Xiaosong C, Nigard L, Kuemmel S, Reitsamer R, Hauschild M, Fulco I, Tausch C, Fischer T, Sarlos D, Constantinescu MA, Lupatsch JE, Fitzal F, Heil J, Matrai Z, de Boniface J, Kurzeder C, Haug M, Weber WP. Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial. BMJ Open. 2021 Sep 2;11(9):e045239. doi: 10.1136/bmjopen-2020-045239.

Reference Type DERIVED
PMID: 34475143 (View on PubMed)

Other Identifiers

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2020-00256; ch18Weber4

Identifier Type: -

Identifier Source: org_study_id