Implant-based breast reconstruction is the commonest form of immediate
breast reconstruction performed in the UK.
Over recent years, practice has changed significantly with the
introduction of biological and synthetic meshes and the use of dermal slings.
There is currently a lack of high-quality evidence to support the safety
or effectiveness of these new techniques and concerns have been raised
regarding high complication rates, particularly when ADMs are used.
A well-designed, multi-centre, prospective study is required to address
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The iBRA (Implant Breast Reconstruction EvAluation) study aims to use the
National Trainee Research Collaborative, an established network of motivated
trainees with an excellent track-record in delivering high-quality prospective
audits and research to:
1. Describe the current practice of immediate implant breast reconstruction
in the UK
2. Evaluate the outcomes of different approaches to immediate implant-based
a) National ABS/BAPRAS standards and quality criteria specified in
ABS/BAPRAS ‘Oncoplastic Breast Reconstruction: Guidelines for Best Practice’.
b) Standard subpectoral implant-based breast reconstructions
3. Determine the feasibility of a long-term prospective study
4. Generate data to inform future best practice guidelines
5. Evaluate the feasibility of a randomised clinical trial comparing
different approaches to implant-based breast reconstruction
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A Trainee Lead (ideally a senior breast trainee) will be identified at
each centre who will be responsible for:
- Obtaining the support of the local team including consultants and
clinical nurse specialists
- Identifying a nominal consultant ‘audit lead’
- Securing local audit approvals prior to recruiting patients to the
- Identifying a small team of trainees to help with the audit
- Completing the National Practice Survey with the support of the
nominated lead consultant in each Unit.
- The National Practice Survey can also be completed online.
- To commence as soon as audit approvals obtained
- Trainees will identify all potentially eligible participants from clinics,
MDTs and surgeons’ operating diaries and recruit them to the audit.
- It is expected that consecutive
patients receiving immediate implant-breast reconstruction after mastectomy for
malignancy or risk reduction at each unit should be included in the study.
- Trainees will collect pre-operative, operative, oncological and 30 day
complication data for each patient.
- All data will be anonymised with a unique study ID number and entered prospectively
on a secure, password-protected electronic database (REDCap) – No patient identifiable
data will be collected in the audit. Paper forms can also be used.
- Trainees will also be responsible for discussing the study with
patients, giving them the patient information sheet and obtaining consent for
PROMs questionnaires to be sent out centrally at 3 and 18 months by post or
e-mail, depending on patient preference by the iBRA study team.
- Individual units may decide on the best logistical process for their
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For a quick reference guide flow chart of how to get started click here
- Data will be analysed every three months and rates of implant loss,
infection, readmission to hospital and re-operation calculated +/- three
- If units fall outside this range, they will be contacted by the iBRA
team and reasons for this explored.
- If a unit falls outside the range for two consecutive analysis periods,
the Clinical Director and Clinical Governance teams at that Unit will be
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Data belongs to each individual unit
What is the authorship
policy for the project?
All participants will be acknowledged in all resulting outputs from
iBRA. There will be two levels of
Citable contributors – participants who recruit at least 10 patients
(with complete datasets) to the audit will be citable via PubMed.
Acknowledged contributors – participants who contribute patients to the
audit, but do not collect data and participants who collect less than the
required amount of data will be acknowledged.
Junior staff will also be given a certificate of participation for their portfolios.
Are you being funded by any of the implant or matrix mesh companies?
Data will be analysed at 3 monthly intervals
If complication rates are >3 standard deviations above the mean this will be fed back to the unit by the iBRA team.
If a unit is an outlier for 2 consecutive analyses, results will be fed back to governance leads.
REDCap is a secure web-based application for building and designing online surveys and data collection tools. It is run out of the University of Edinburgh, under licence of the Vanderbilt University. Security information can be seen on the REDCap website
. To get a user name please contact us
once you have audit department approval to begin the project, and we can arrange online data collection access. If you do not have online access you can still use the paper copies of the forms. Both collect the same information.
The iBRA Study
Office Room 3.12
The University of Bristol
39 Whatley Road
If you have entered data into the iBRA study, or if you are a Consultant who has entered patients, click this link to a summary of all the presentations that you can put on your CV.
We have had great response to the iBRA study and have already exceeded our initial target of 1000 ladies participating. However, there appears to be both a lower than predicted complication rate and also the emergence of new types of mesh, including pre-pectoral techniques. We would really like to be able to make a meaningful comment on the newer techniques especially. We have therefore made the decision to extend recruitment until Summer 2016.