The Pre-BRA study
(Pre-pectoral Breast Reconstruction Evaluation)
A mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant based breast reconstruction.
Background: Implant-based breast reconstruction (IBBR) is the most commonly-performed reconstructive technique worldwide. Sub-pectoral reconstruction with mesh is the current standard of care but new pre-pectoral techniques have recently been introduced. Pre-pectoral breast reconstruction (PPBR) may improve outcomes for patients by reducing post-operative pain and avoiding potentially distressing implant ‘animation’.
Although the results of PPBR are promising in the hands of expert surgeons, robust evaluation is required before the technique can be recommended as standard practice. Randomised clinical trials (RCTs) are ideally-needed but the short-term safety of PPBR is yet to be established; the technique and its indications are evolving and it has yet to be adopted by a sufficient number of surgeons for an RCT to be feasible.
Study description: Pre-BRA is an IDEAL stage 2a/2b prospective multicentre cohort study with embedded qualitative research.
Aims: Pre-BRA aims to determine the feasibility of using mixed-methods within an IDEAL 2a/2b study to explore the short-term safety of PPBR and determine when the technique is sufficiently stable for evaluation in a pragmatic RCT.
Specific objectives are to determine
i. The safety and effectiveness of PPBR including implant loss, infection, re-operation and readmission at 3 months; post-operative pain scores and 3 and 18 month patient reported outcome using the validated BREAST-Q questionnaire
ii. The feasibility of using mixed methods to share surgical learning and determine when the technique is stable
iii. To inform the design of a future RCT.
Inclusion criteria - Female patients aged 16 or over electing to undergo immediate prepectoral implant based breast reconstruction for breast cancer or risk reduction using any technique or product;
exclusion criteria: delayed reconstruction or revisional surgery
Primary outcome: implant loss at 3 months
Sample size 341
Ethical approvals: PreBRA has received full ethical approval from OXFORD-B South Central Committee Ref:19/SC/0129 and is registered on the CRN portfolio.
Funding: The Pre-BRA Study is funded by the Royal College of Surgeons of England; NIHR Bristol Biomedical Research Centre and the Association of Breast Surgery
Team: Shelley Potter (Co – Chief investigator), Chris Holcombe (Co-CI), Kate Harvey (MD student), Parisa Sinai (Trial Manager), Mairead MacKenzie (PPI lead), Paul White (Study Statistician)
Steering group members: Simon Cawthorn, Tim Rattay, Pankaj Roy, Soni Soumian, Georgette Oni, Joanna Skillman, Peter Barry, Shireen McKenzie, Rachel O’Connell, Matthew Gardiner, Samantha Williams, Raghavan Vidya
Contact details: Please contact the Pre-BRA study team firstname.lastname@example.org for more information and to get involved