The Pre-Bra Feasibility Study
Research type
Research Study
Full title
The Pre-Bra (Pre-Pectoral Breast Reconstruction Evaluation) Feasibility Study. An IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant based breast reconstruction
IRAS ID
255421
Contact name
Shelley Potter
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
55,000 women are diagnosed with breast cancer each year in the UK. 40% undergo mastectomy and of those who choose breast reconstruction, most have an implant-based operation. “Mesh” refers to a biological or plastic material which is used as a scaffold to support a breast implant during reconstruction. Sub-pectoral implant-based reconstruction, placing a breast implant and mesh underneath the chest wall muscle, has become standard despite a lack of evidence to support its use.
A new technique has developed in which a breast implant is completely covered in mesh and placed in-front of the chest-wall muscle rather than underneath. This may result in less pain and more natural results, but this has yet to be established. However, pre-pectoral breast reconstruction (PPBR) is already being performed and is gaining popularity. There is a need to robustly evaluate this technique before it becomes standard.
The Pre-Bra Study is a multi-centre prospective cohort study using mixed qualitative and quantitative methods to determine the safety and effectiveness of PPBR. Female patients aged 16 or over choosing to undergo PPBR for breast cancer or risk reduction are eligible. The study will recruit patients from breast surgery departments in the UK with consultants already performing PPBR. After giving consent, patients will be asked to complete a breast-surgery specific questionnaire (Breast-Q) and rate pain levels. Demographic, clinical, intra-operative, additional treatment and complication data will be collected for the first 3 post-operative months. All patients will be asked to complete the validated BREAST-Q questionnaire at 3 and 18 months. A selected group of surgeons will be interviewed to establish how they began using the novel technique, how they modified it over time and what changes they make when complications occur.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0129
Date of REC Opinion
10 May 2019
REC opinion
Further Information Favourable Opinion