Evidence map›Paper›PMID 34475143›Full record

Trial reportBMJ open2021

Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial.

Elisabeth A Kappos, Alexandra Schulz, Meredith M Regan, Giusi Moffa, Yves Harder, Karin Ribi, Shelley Potter, Andrea L Pusic, Mathias K Fehr, Lars G Hemkens and 33 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04293146 (Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04293146 naactive not recruitingnot on this map

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

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2020 to 2033Enrolled382ConditionsBreast Reconstruction, Implant-Based Breast Reconstruction (IBBR)Armspre-pectoral IBBR, sub-pectoral IBBR
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Immediate prepectoral versus submuscular breast reconstruction in nipple-sparing mastectomy: a retrospective cohort analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2024
    Article
  8. Article
  9. Article
  10. Article
  11. A review of different breast reconstruction methods.American journal of translational research · 2023
    Review
  12. Article
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  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

43 authors.

Elisabeth A KapposBreast Center, University Hospital Basel, University of Basel, Basel, Switzerland elisabeth.kappos@usb.ch.ORCID 0000-0003-4057-1951
Alexandra SchulzUniversity of Basel, Basel, Switzerland.
Meredith M ReganIBCSG Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Giusi MoffaDepartment of Mathematics and Computer Science, University of Basel, Basel, Switzerland.
Yves HarderDepartment of Plastic, Reconstructive and Aesthetic Surgery, Ospedale Regionale di Lugano and Centro di Senologia della Svizzera Italiana, Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland.
Karin RibiQuality of Life Office, International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.ORCID 0000-0003-4724-1197
Shelley PotterCentre for Surgical Research, Bristol Medical School and Bristol Breast Care Centre, North Bristol NHS Trust, University of Bristol, Bristol, UK.ORCID 0000-0002-6977-312X
Andrea L PusicDivision of Plastic and Reconstructive Surgery, Department of Surgery, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Mathias K FehrDepartment of Gynecology and Obstetrics, Cantonal Hospital Frauenfeld, Frauenfeld, Switzerland.
Lars G HemkensUniversity of Basel, Basel, Switzerland.
Thomas HolzbachDepartment of Hand and Plastic Surgery, Spital Thurgau AG, Frauenfeld, Thurgau, Switzerland.
Jian FarhadiUniversity of Basel, Basel, Switzerland.
Colin SimonsonBrustzentrum Spital Sitten, Sitten, Switzerland.
Michael KnauerBreast Center Eastern Switzerland, St. Gallen, Switzerland.
Ralph VerstappenBreast Center St. Gallen, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.
Heiner C BucherUniversity of Basel, Basel, Switzerland.
Daniel ZwahlenDepartment of Radiation Oncology, Kantonsspital Winterthur, Winterthur, Switzerland.
Frank ZimmermannUniversity of Basel, Basel, Switzerland.
Matthias SchwenkglenksInstitute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
Rosine MucklowIndependent patient expert, Buxtorf Quality Services, Basel, Switzerland.
Jane ShawPatient Advocacy Group, Oncoplastic Breast Consortium, Basel, Switzerland.
Vesna Bjelic-RadisicBreast Unit, University Hospital Helios Wuppertal, University Witten Herdecke, Wuppertal, Germany.
Amelia ChiorescuDepartment of Breast, Endocrine tumours and Sarcoma, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.
Yoon S ChunDivision of Plastic and Reconstructive Surgery, Department of Surgery, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Subrina FarahIBCSG Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Chen XiaosongComprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Linda NigardSödersjukhuset, Bröstsektionen, Kirurgkliniken, Stockholm, Sweden.
Sherko KuemmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany.
Roland ReitsamerBreast Center Salzburg, University Clinic Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria.
Maik HauschildDepartment of Gynecology and Obstetrics, Gesundheitszentrum Fricktal, Rheinfelden, Switzerland.
Ilario FulcoBreast Center, University Hospital Basel, University of Basel, Basel, Switzerland.
Christoph TauschBreast Center Zurich, Zurich, Switzerland.
Thomas FischerLindenhofgruppe, Centerclinic, Brustzentrum Bern, Bern, Switzerland.
Dimitri SarlosDepartment of Obstetrics and Gynecology, Kantonsspital Aarau AG, Aarau, Switzerland.
Mihai A ConstantinescuDepartment of Plastic and Hand Surgery, Inselspital University Hospital, Bern, Switzerland.
Judith E LupatschInstitute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
Florian FitzalBreast Health Center and Department of Surgery, Medical University, Vienna, Austria.
Joerg HeilDepartment of Obstetrics and Gynecology, University Breast Unit, University Women's Hospital Heidelberg, Heidelberg, Germany.
Zoltan MatraiNational Institute of Oncology, Department of Breast and Sarcoma Surgery, Budapest, Hungary.
Jana de BonifaceDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Christian KurzederBreast Center, University Hospital Basel, University of Basel, Basel, Switzerland.
Martin HaugBreast Center, University Hospital Basel, University of Basel, Basel, Switzerland.
Walter P WeberBreast Center, University Hospital Basel, University of Basel, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.

Indexed as

Breast ImplantationBreast ImplantsBreast NeoplasmsMammaplastyFemaleHumansMastectomyNipplesbreast surgerybreast tumourscancer geneticsgynaecological oncologyplastic & reconstructive surgeryprotocols & guidelines

Identifiers

PMID34475143
PMCPMC8413865

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.