{"registry": "ISRCTN", "registryId": "ISRCTN37664281", "source": "https://www.isrctn.com/ISRCTN37664281", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN37664281/format/default", "fetchedAt": "2026-10-07T17:01:01.708814Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "The iBRA (implant breast reconstruction evaluation) study", "scientificTitle": "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", "acronym": "The iBRA (implant Breast Reconstruction evAluation) Study", "hypothesis": "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.", "primaryOutcome": "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. \nThe following specific progression criteria will be reviewed at 30 months:  \n1. 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 \n2. 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. \n3. 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.\n4. 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.\n5. Feasibility of using the trainee collaborative model to recruit patients and follow them up with <10% missing data over all the specified time points.", "secondaryOutcome": "Optimal design and conduct of the RCT", "intervention": "\n\tPhase 1 – A national practice questionnaire (NPQ)\n\nThe 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: \n1. To establish the number of centres and surgeons able and willing to participate in a future trial. \n2. To determine the incidence of each type of IBBR being performed at centre and surgeon level (informing trial design and sample size)\n3. To examine how surgeons select suitable patients for surgery (informing the inclusion criteria)\n4. To determine how the implant procedures are performed at centre level, especially how lower-pole coverage is achieved (informing trial design) \n5. 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 \n6. To engage surgeons to develop an appreciation of the need for RCTs in IBBR\n\nPhase 2 – A prospective cohort study of patients undergoing implant-based breast reconstruction\n\nThe 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:\n1. To determine how implant procedures are carried out at centre level, especially how lower-pole coverage is achieved (informing trial design) \n2. 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 \n3. 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).\n4. To explore the ability of the BREAST-Q to discriminate between procedure-subtypes and hence its value for use in a future trial  \n5. 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 \n\nCentres 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. \n\nThe 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.\n\nPotential 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.\n\nTrainees 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.\n\nPhase 3–  An IBBR-RCT acceptability-survey to explore patients’ and surgeons’ views of proposed trial designs.  \n\nThe 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:\n1. To determine the proportion of patients and surgeons willing and able to participate in each candidate study design\n2. To determine patients’ and surgeons’ views regarding the most appropriate primary outcome for the definitive trial\n3. 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\n4. To explore barriers and facilitators to potential participation in an RCT in IBBR and how these challenges may be overcome\n\nUsing 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.  \n\nA 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\n\nPhase 4 - Design of the definitive RCT\n\nThe feasibility, design and conduct of a definitive RCT will be determined by the outcomes of phases 1-3\n\tProcedure/Surgery\n\t\n\t\n      ", "condition": "\n\tImplant-based breast reconstruction following mastectomy for breast cancer or risk reduction\n\tCancer\n\t\n      ", "studyDesign": "Multi-centre prospective observational cohort study", "overallEndDate": "2018-05-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2021-11-16T14:46:16.357Z", "eligibility": {"inclusion": "1. Female patients\n2. Undergoing immediate IBBR for malignancy or risk-reduction under the care of the breast or plastic surgeons", "exclusion": "1. Women undergoing delayed breast reconstruction\n2. Revisional surgery\n3. Patients not willing or able to provide informed consent for the patient reported outcomes part of the study", "ageRange": "Adult", "gender": "Female", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2014-02-04T00:00:00.000Z", "recruitmentEnd": "2016-06-30T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "0", "totalFinalEnrolment": "2108"}, "countries": ["United Kingdom", "England", "Northern Ireland", "Wales"], "locations": [{"name": "Royal Liverpool University Hospital", "city": "", "state": "", "country": "United Kingdom", "zip": "L7 8XP"}, {"name": "Nottingham Breast Institute", "city": "", "state": "", "country": "United Kingdom", "zip": "NG5 1PB"}, {"name": "New Cross Hospital Wolverhampton", "city": "", "state": "", "country": "United Kingdom", "zip": "WV10 0QP"}, {"name": "Royal Marsden Hospital", "city": "", "state": "", "country": "United Kingdom", "zip": "SW3 6JJ"}, {"name": "University Hospitals South Manchester", "city": "", "state": "", "country": "United Kingdom", "zip": "M23 9LT"}, {"name": "Brighton and Sussex University Hospitals NHS Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "BN1 6AG"}, {"name": "East Lancashire NHS Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "BB10 2PQ ."}, {"name": "Arrowe Park Hospital - Wirral University Teaching Hospital NHS Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "CH49 5PE"}, {"name": "Barts Health NHS Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "E1 2AD"}, {"name": "Leeds Teaching Hospitals NHS Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "LS9 7LN"}, {"name": "Belfast Health and Social Care Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "BT9 7AB"}, {"name": "Worcester Acute NHS Trust", "city": "", "state": "", "country": "United Kingdom", "zip": "WR5 1DD"}, {"name": "The Newcastle on Tyne Hospitals 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