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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, pre-pectoral techniques being introduced. These muscle-sparing techniques may reduce post-operative 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 pre 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 pre and subpectoral techniques.
Methods and analysis
Best-BRA is a pragmatic, two-arm, external pilot randomised controlled trial 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 pre 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 i) recruitment of patients, ii) adherence to trial allocation and iii) 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 NHS Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.
Trial registration
ISRCTN10081873.
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, pre-pectoral techniques being introduced. These muscle-sparing techniques may reduce post-operative 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 pre 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 pre and subpectoral techniques.
Methods and analysis
Best-BRA is a pragmatic, two-arm, external pilot randomised controlled trial 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 pre 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 i) recruitment of patients, ii) adherence to trial allocation and iii) 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 NHS Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.
Trial registration
ISRCTN10081873.
| Original language | English |
|---|---|
| Article number | e050886 |
| Number of pages | 10 |
| Journal | BMJ Open |
| Volume | 11 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - 30 Nov 2021 |
Structured keywords
- HEB
Keywords
- implant-based breast reconstruction
- pre-pectoral
- subpectoral
- pilot trial
- randomised controlled trial
- QuinteT Recruitment Intervention (QRI)
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The BRAVER Study - Methods to develop less and better research in reconstructive breast surgery
1/03/17 → 31/08/23
Project: Research