The iBRA (implant breast reconstruction evaluation) study

ISRCTN	ISRCTN37664281
DOI	https://doi.org/10.1186/ISRCTN37664281
Protocol serial number	N/A
Sponsor	University of Bristol (phase 3 only)
Funders	National Institute for Health Research, Association of Breast Surgery (pump-priming), British Association of Plastic Aesthetic and Reconstructive Surgeons (pump-priming)

Submission date: 20/01/2016
Registration date: 04/02/2016
Last edited: 16/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Shelley Potter
Scientific

Room 3.12 Canynge Hall
School of Social and Community Medicine
University of Bristol
Bristol
BS8 2PS
United Kingdom

Study information

Primary study design	Observational
Study design	Multi-centre prospective observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	The iBRA (implant Breast Reconstruction evAluation) Study - a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant breast reconstuction
Study acronym	The iBRA (implant Breast Reconstruction evAluation) Study
Study objectives	Implant-based breast reconstruction (IBBR) is the most commonly-performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionalised the procedure, but there is a lack of high-quality outcome data to support the safety or efficacy of these techniques. Randomised clinical trials (RCTs) are the best way of comparing treatments but surgical RCTs are challenging. The iBRA (implant Breast Reconstruction evAluation) study aims to inform the feasibility, design and conduct of a pragmatic-RCT to examine the effectiveness of new approaches to IBBR.
Ethics approval(s)	Phases 1 & 2 do not require ethical approval because they involve the routine collection of clinical and patient reported outcome data as recommended by the 'Oncoplastic Surgery. Guidelines for Good Practice'. This has been agreed with the host organisations. Ethical approval will be obtained for Phase 3, the randomisation acceptability survey as this does constitute research. The University of Bristol will act as the sponsor and proportional ethics review will be obtained prior to commencing this phase of the study.
Health condition(s) or problem(s) studied	Implant-based breast reconstruction following mastectomy for breast cancer or risk reduction
Intervention	Phase 1 – A national practice questionnaire (NPQ) The aim of phase 1 is to understand the current practice of implant-based breast reconstruction in the UK to inform the design of a definitive RCT. Specific objectives of phase 1 are: 1. To establish the number of centres and surgeons able and willing to participate in a future trial. 2. To determine the incidence of each type of IBBR being performed at centre and surgeon level (informing trial design and sample size) 3. To examine how surgeons select suitable patients for surgery (informing the inclusion criteria) 4. To determine how the implant procedures are performed at centre level, especially how lower-pole coverage is achieved (informing trial design) 5. To establish current practice of pre and post-surgical care in IBBR which will inform the use and standardisation of concomitant interventions in the trial 6. To engage surgeons to develop an appreciation of the need for RCTs in IBBR Phase 2 – A prospective cohort study of patients undergoing implant-based breast reconstruction The aim of Phase 2 is to understand the practice and outcomes of IBBR in the UK to inform the design of a definitive RCT. Specific objectives of phase 2 are: 1. To determine how implant procedures are carried out at centre level, especially how lower-pole coverage is achieved (informing trial design) 2. To evaluate the practicality of obtaining clinical and patient-reported outcome data and the feasibility of trainees recruiting patients and collecting longitudinal data, with a view to using this approach in a future trial 3. To determine the outcomes of different approaches to IBBR. Including identifying risk factors for adverse outcomes such as the impact of the learning curve (informing entry criteria, primary and secondary outcomes and parameters required for a power calculation). 4. To explore the ability of the BREAST-Q to discriminate between procedure-subtypes and hence its value for use in a future trial 5. To engage and educate consultants and trainees to establish an appreciation of the need for, and a desire to participate in, a future trial in IBBR Centres identified as performing immediate IBBR from the NPQ (Phase 1) will be eligible to progress to Phase 2, the prospective cohort study. The named supervising consultant will act as the principal investigator for each unit and trainee leads will be responsible for recruitment and data collection. The study will be piloted in two centres (Liverpool and Bristol) prior to national roll-out to evaluate feasibility and effectiveness of trainee involvement in recruitment and data collection. Methods of data management will also be assessed. Potential participants will be identified prospectively by the local study team via clinics, local MDTs, consultant surgeons and clinical nurse specialists. Simple demographic, procedure and process data will be collected for each participant. Data will be recorded in an anonymised format using a unique alphanumeric study identification number on a secure web-based database. In-hospital complication data will be collected prospectively by trainee leads. Patients will be reviewed in clinic at 30 days to collect complication and oncology data. Note-review will be performed in patients who do not attend for 30 day follow-up. Trainees or a locally-designated member of team will approach patients in clinic or during their admission to obtain consent for PROMs assessment. Individual centres will be free to determine the optimal approach for recruiting patients to this part of the study. PROMs assessment will be by post or e-mail, dependent on patient preference, at 3 and 18-months (for those eligible for long-term assessment) following surgery and will evaluate satisfaction with care, complications and health-related quality of life (BREAST-Q). If consent is obtained, contact details will be sent securely to the co-ordinating centre and questionnaires distributed centrally to optimise compliance, allow accurate follow-up and reduce the incidence of missing data. Phase 3– An IBBR-RCT acceptability-survey to explore patients’ and surgeons’ views of proposed trial designs. The aim of Phase 3 is to investigate the acceptability to patients and surgeons of candidate trial designs generated from phases 1 and 2 to determine a suitable design to progress to a definitive, pragmatic trial. Specific objectives of phase 3 are: 1. To determine the proportion of patients and surgeons willing and able to participate in each candidate study design 2. To determine patients’ and surgeons’ views regarding the most appropriate primary outcome for the definitive trial 3. To determine the degree of pragmatism (e.g. product selection; technique; variation in pre/peri/post-operative care) that would be acceptable and feasible to surgeons in the definitive trial 4. To explore barriers and facilitators to potential participation in an RCT in IBBR and how these challenges may be overcome Using phase 1 and 2 data, two RCT acceptability surveys (RCTAS) (one each for patients and surgeons) will be developed by members of the steering group. Respondents will communicate their willingness to participate in different candidate trials; give opinions regarding primary outcomes and surgeons will offer views about the degree of pragmatism that would be acceptable in a future trial. A qualitative research component will be integrated into Phase 3 of the study to provide an in-depth exploration of the acceptability of proposed trial designs and expand on findings from the questionnaire survey. Respondents to the questionnaire who are willing to be contacted will be purposively sampled and interviewed to explore common and unusual questionnaire responses to enable a more detailed understanding of the acceptability of proposed study designs. Patients and surgeons will be interviewed (with the final number depending on data saturation) using a flexible topic guide to investigate their views on willingness to participate in the proposed study designs, appropriate outcome measures and, for surgeons, the degree of pragmatism that would be acceptable and feasible in the definitive trial Phase 4 - Design of the definitive RCT The feasibility, design and conduct of a definitive RCT will be determined by the outcomes of phases 1-3
Intervention type	Procedure/Surgery
Primary outcome measure(s)	The feasibility study will determine the most appropriate study design. The primary outcome will be identified and outcome data used to inform a sample size calculation. Information from rates of surgery and patient selection criteria will be combined with estimates of surgeon and centre willingness to participate in a trial to assess the feasibility of undertaking a definitive trial that would achieve target recruitment within 3 years. The following specific progression criteria will be reviewed at 30 months: 1. At least 40% of surgeons and patients responding to the RCT-Acceptability Survey can agree to participate in an RCT in implant-based breast reconstruction surgery 2. The cohort study data and findings of the RCT-Acceptability Surveys (for patients and surgeons) and qualitative work provide sufficient information to inform the selection of an acceptable and appropriate primary outcome measure to inform the sample size required for main study. 3. Based on the sample size calculation for the chosen primary outcome, the number of centres willing to participate, the anticipated patient consent rate, and data from the incident numbers of patients that are likely to be eligible to participate in a RCT, including information about reconstructive techniques used and to be compared in the trial, the study will be practical and achievable with three years of recruitment. Data from an analysis of NIHR portfolio data (Kaur, MRC North West Hub for Trials Methodology Research, personal communication) shows that the trials recruiting to time and target did so with a median recruitment period of 13 months, interquartile range 8 to 24. 42/45 (93%) recruited successfully within three years. Although these data are for paediatric trials, there is no obvious reason why the results would not be generalisable to recruitment in adult studies. 4. Data from the surveys show that a sufficient number of centres, each with a minimum of 2 participating surgeons are willing and able to participate in the main trial. 5. Feasibility of using the trainee collaborative model to recruit patients and follow them up with <10% missing data over all the specified time points.
Key secondary outcome measure(s)	Optimal design and conduct of the RCT
Completion date	30/05/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Total final enrolment	2108
Key inclusion criteria	1. Female patients 2. Undergoing immediate IBBR for malignancy or risk-reduction under the care of the breast or plastic surgeons
Key exclusion criteria	1. Women undergoing delayed breast reconstruction 2. Revisional surgery 3. Patients not willing or able to provide informed consent for the patient reported outcomes part of the study
Date of first enrolment	04/02/2014
Date of final enrolment	30/06/2016

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Wales

Study participating centres

Royal Liverpool University Hospital

L7 8XP
United Kingdom

Nottingham Breast Institute

NG5 1PB
United Kingdom

New Cross Hospital Wolverhampton

WV10 0QP
United Kingdom

Royal Marsden Hospital

SW3 6JJ
United Kingdom

University Hospitals South Manchester

M23 9LT
United Kingdom

Brighton and Sussex University Hospitals NHS Trust

BN1 6AG
United Kingdom

East Lancashire NHS Trust

BB10 2PQ .
United Kingdom

Arrowe Park Hospital - Wirral University Teaching Hospital NHS Trust

CH49 5PE
United Kingdom

Barts Health NHS Trust

E1 2AD
United Kingdom

Leeds Teaching Hospitals NHS Trust

LS9 7LN
United Kingdom

Belfast Health and Social Care Trust

BT9 7AB
United Kingdom

Worcester Acute NHS Trust

WR5 1DD
United Kingdom

The Newcastle on Tyne Hospitals NHS Foundation Trust

NE1 4LP
United Kingdom

Frimley Health NHS Foundation Trust

GU16 7UJ
United Kingdom

Bolton NHS Foundation Trust

BL4 0JR
United Kingdom

Royal Devon and Exeter NHS Foundation Trust

EX2 7JU
United Kingdom

University Hospitals Coventry and Warwickshire

CV2 2DX
United Kingdom

West Hertfordshire Hospitals NHS Trust

HP2 4AD
United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

S10 2JF
United Kingdom

University Hospitals of Leicester NHS Trust

LE3 9QP
United Kingdom

Airedale NHS Foundation Trust

BD20 6TD
United Kingdom

University Hospitals Birmingham NHS Foundation Trust

B15 2WB
United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust

FY3 8NR
United Kingdom

Homerton University Hospitals NHS Foundation Trust

E9 6SR
United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

BD9 6RJ
United Kingdom

Luton and Dunstable University Hospital

LU4 0DZ
United Kingdom

Dorset County Hospital NHS Foundation Trust

DT1 2JY
United Kingdom

North Bristol NHS Trust

BS10 5NB
United Kingdom

Milton Keynes University Hospital NHS Foundation Trust

MK6 5LD
United Kingdom

Musgrove Park Hospital

TA1 5DA
United Kingdom

Royal Berkshire NHS Foundation Trust

RG1 5AN
United Kingdom

Royal Surrey County NHS Foundation Trust

GU2 7XX
United Kingdom

Northern Lincolnshire and Goole NHS Foundation Trust

DN15 7BH
United Kingdom

York Teaching Hospital NHS Foundation Trust

YO31 8HE
United Kingdom

Peterborough and Stamford Hospitals NHS Foundation Trust

PE3 9GZ
United Kingdom

Royal United Hospital NHS Foundation Trust

BA1 3NG
United Kingdom

Aneurin Bevan University Health Board

NP7 7EG
United Kingdom

Countess of Chester NHS Foundation Trust

CH2 1UL
United Kingdom

University Hospitals North Stafford

ST4 6QG
United Kingdom

Great Western Hospitals NHS Foundation Trust

SN3 6BB
United Kingdom

St Helens and Knowsley Teaching Hospitals NHS Trust

L35 5DR
United Kingdom

Portsmouth Hospitals NHS Trust

PO6 3LY
United Kingdom

University Hospitals Durham

DH1 5TW
United Kingdom

Royal Hampshire County Hospital

SO22 5DG
United Kingdom

Hull and East Yorkshire Hospitals NHS Trust

HU16 5JQ
United Kingdom

Cardiff and Vale University Health Board

CF64 2XX
United Kingdom

Barnsley Hospital NHS Foundation Trust

S75 2EP
United Kingdom

Poole Hospital NHS Foundation Trust

BH15 2JB
United Kingdom

Ashford and St Peter's Hospitals NHS Foundation Trust

KT16 0PZ
United Kingdom

Chesterfield Royal Hospital -NHS Foundation Trust

S44 5BL
United Kingdom

Warrington and Halton Hospitals NHS Foundation Trust

WA5 1QG
United Kingdom

Southern Health and Social Care Trust

BT63 5QQ
United Kingdom

University College Hospitals London

NW1 2BU
United Kingdom

South Warwickshire NHS Foundation Trust

CV34 5BW
United Kingdom

University Hospital Southampton NHS Foundation Trust

SO16 6YD
United Kingdom

Kettering General Hospital NHS Foundation Trust

NN16 8UZ
United Kingdom

Yeovil District Hospital NHS Foundation Trust

BA21 4AT
United Kingdom

Salisbury NHS Foundation Trust

SP2 8BJ
United Kingdom

Torbay and South Devon NHS Foundation Trust

TQ2 7AA
United Kingdom

Isle of Wight NHS Trust

PO30 5TG
United Kingdom

St Georges London

SW17 0QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2019	16/01/2019	Yes	No
Results article	qualitative interview results	06/04/2020	08/04/2020	Yes	No
Results article	results	09/07/2020	23/07/2020	Yes	No
Results article		08/01/2021	16/11/2021	Yes	No
Protocol article	protocol	04/08/2016	23/07/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/11/2021: Publication reference added.
23/07/2020: Publication references added.
08/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2019 reference.
16/01/2019: Publication reference added.
26/10/2017: Internal review.
13/07/2016: Internal review.