Kirsty Roberts
Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): A protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy
Roberts, Kirsty; Mills, Nicola; Metcalfe, Chris; Lane, Athene; Clement, Clare; Hollingworth, William; Taylor, Jodi; Holcombe, Chris; Skillman, Joanna; Fairhurst, Katherine; Whisker, Lisa; Cutress, Ramsey; Thrush, Steven; Fairbrother, Patricia; Potter, Shelley
Authors
Nicola Mills
Chris Metcalfe
Athene Lane
Clare Clement
William Hollingworth
Jodi Taylor
Chris Holcombe
Joanna Skillman
Katherine Fairhurst
Lisa Whisker
Ramsey Cutress
Steven Thrush
Patricia Fairbrother
Shelley Potter
Abstract
Background Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques. Methods and analysis Best-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques. The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients. Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial. Ethics and dissemination The study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals. Trial registration number ISRCTN10081873.
Journal Article Type | Article |
---|---|
Acceptance Date | Nov 1, 2021 |
Online Publication Date | Nov 30, 2021 |
Publication Date | Nov 30, 2021 |
Deposit Date | Jun 26, 2024 |
Publicly Available Date | Jun 27, 2024 |
Journal | BMJ Open |
Electronic ISSN | 2044-6055 |
Publisher | BMJ Publishing Group |
Peer Reviewed | Peer Reviewed |
Volume | 11 |
Issue | 11 |
Article Number | e050886 |
DOI | https://doi.org/10.1136/bmjopen-2021-050886 |
Public URL | https://uwe-repository.worktribe.com/output/12084607 |
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Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): A protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mast
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Licence
http://creativecommons.org/licenses/by/4.0/
Publisher Licence URL
http://creativecommons.org/licenses/by/4.0/
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