In:
BMJ Open, BMJ, Vol. 11, No. 9 ( 2021-09), p. e045239-
Abstract:
The 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 .
Type of Medium:
Online Resource
ISSN:
2044-6055
,
2044-6055
DOI:
10.1136/bmjopen-2020-045239
Language:
English
Publisher:
BMJ
Publication Date:
2021
detail.hit.zdb_id:
2599832-8
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