A mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant based breast reconstruction
About the Study
Each year 55,000 women are diagnosed with breast cancer in the UK. Of these, approximately 40% undergo mastectomy and breast reconstruction is offered to improve women’s quality of life.
Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. Techniques have evolved with the introduction of mesh-assisted single stage direct to implant reconstruction and most recently pre-pectoral techniques but there is no high-quality evidence to support best practice.
Pre-BRA (Pre-pectoral Breast Reconstruction Evaluation) is an IDEAL stage 2a/2b observational cohort study that aims to explore the safety and efficacy of prepectoral implant based breast reconstruction. The IDEAL framework provides system for evaluating surgical innovations from ‘first in human’ (stage 1) to ‘long term study’ (stage 4). This IDEAL stage 2a/2b study aims to ensure prepectoral reconstruction is a safe and stable technique before proceeding to definitive evaluation in a randomised clinical trial.
The primary outcome is implant loss at 3 months following reconstructive surgery.
Based on the assessment of the breast reconstruction options available to patients, participating breast or plastic surgeons recruit patients into the study.
The trial will run to February 2022. A total of 340 women will take part across more than 40 breast reconstruction centres across England, Scotland and Wales.
Population Health Sciences
Bristol Medical School
University of Bristol
39 Whatley Road
PreBRA mobile: 07815 684 182
The PreBRA Feasibility Study is funded by The Bristol NIHR Biomedical Research Centre, The Royal College of Surgeons of England and The Association of Breast Surgeons.
The trial is led and sponsored by the University of Bristol. It is hosted by NHS North Bristol Trust.
Approved 10/05/2019, NHS HRA South Central - Oxford B Research Ethics Committee ; ref: 19/SC/0129