The no mesh breast reconstruction evaluation (No-BRA) study: protocol for a national prospective audit and shared learning study of pre-pectoral implant-based breast reconstruction with no mesh
Jing Qin Tay, Thessa R. Friebel, Daniel Kyle, Ramsey Cutress, Joe M. O’Donoghue, Shelley Potter, Rachel Rolph, Robert H. Thomas, Julie Wray, Rebecca L. WilsonIntroduction:
Implant-based breast reconstruction (IBBR) is the most common reconstructive modality for women undergoing mastectomy in the United Kingdom (UK). Practice has evolved from subpectoral to pre-pectoral implant placement, typically utilizing a mesh for implant support. A newer iteration of this technique, which omits the use of mesh entirely, is gaining popularity but lacks a robust evidence base regarding its safety, effectiveness, and optimal application. This study is positioned within phases 2a/2b of the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) framework to formally evaluate this surgical innovation. The No-BRA study aims to conduct a national audit to explore the safety and effectiveness of immediate pre-pectoral IBBR without mesh to inform the delivery of best care.
Methods and analysis:
This is a national, multicenter, prospective audit aiming to recruit 350 patients from 15 to 20 UK centers. The study employs a dual-component design. The first component is a quantitative audit of clinical and patient-reported outcome measures (PROMs) for women undergoing immediate pre-pectoral IBBR with no mesh. The primary outcome is implant loss at 3 months post-surgery. Secondary outcomes include other key complications (e.g., infection, unplanned re-operation, and readmission) and PROMs (preoperatively, at 1.5 and 5 years), which will be benchmarked against established national standards. The second component is an integrated qualitative study of the surgeon’s perspective designed to capture and disseminate learning. Quantitative data will be analyzed using descriptive statistics and exploratory risk factor analysis. Qualitative data will undergo thematic analysis using a constant comparative approach.
Dissemination:
All data are managed confidentially using a secure REDCap database. The results will be disseminated through peer-reviewed publications and conference presentations, as well as a dynamic feedback loop to the participating surgical community via newsletters.