{"registry": "ISRCTN", "registryId": "ISRCTN11898000", "source": "https://www.isrctn.com/ISRCTN11898000", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN11898000/format/default", "fetchedAt": "2026-10-07T17:01:22.618756Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "The pre-pectoral breast reconstruction evaluation study", "scientificTitle": "The Pre-pectoral Breast Reconstruction Evaluation Feasibility Study - a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant-based breast reconstruction", "acronym": "Pre-Bra", "hypothesis": "Current study hypothesis as of 08/04/2020:\nPre-pectoral breast reconstruction is safe and the technique is stable and ready for evaluation in a definite randomised controlled trial.\n\nPrevious study hypothesis:\nPre-pectoral breast reconstruction is safe and results in levels of pain and implant animation following surgery which are acceptable to patients.", "primaryOutcome": "Current primary outcome measure as of 08/04/2020:\nImplant loss rate at 3 months defined as: any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery \n\nPrevious primary outcome measure:\nImplant loss rate at 3 months will be determined by clinical review carried out by participating surgeons at participating clinical sites. Implant loss is defined as: \"any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery.\"", "secondaryOutcome": "Current secondary outcome measures as of 08/04/2020:\n1. Other key safety measures including infection, return to theatre and reoperation, measured by clinical review at 3 months \n2. Post-operative pain scores measured by VAS at 24 hours, 48 hours, 1 week and 3 months\n3. Patient satisfaction with the outcome of their reconstruction assessed using the ‘satisfaction with breasts’ domain of the BREAST-Q at 18 months\n4. Other patient-reported outcomes included in the breast reconstruction core outcome set including physical function, emotional well being and animation assessed using the BREAST-Q at 18 months\n5. The feasibility of using mixed methods to promote shared learning and determine if the procedure is sufficiently stable for evaluation in the context of an RCT\n6. The proportion of surgeons reporting modifications/complications; of these\n7. The proportion of CRFs including details of modifications or learning arising from complications; of these\n8. The proportion of surgeons agreeing to be interviewed; and of these\n9. The proportion of interviews performed\n\nPrevious secondary outcome measures:\n1. Safety will be determined by comparing key safety outcomes for pre-pectoral breast reconstruction including infection; return to theatre and readmission at 3 months with published national audit data. All 3 measures will be determined by clinical teams and reported to the central study team as they occur. Definitions of all 3 measures are:\n1.1. Infection- A hot, red swollen breast associated with one of the following; a temperature, pus at the wound site, a raised white cell count and/or; a positive wound swab within the first 3 months following surgery. This will be further classified as: \n1.1.1. Minor – requiring oral antibiotics only; \n1.1.2. Major 1 – requiring admission for IV antibiotics and/or debridement; \n1.1.3. Major 2 – requiring surgical drainage/debridement\n1.2. Readmission to hospital– any re-admission to hospital in the 3 months following surgery directly related to the procedure (e.g. with infection requiring antibiotics).\n1.3. Return to theatre – Return to the operating theatre at any time during the first 3 months following surgery to deal with any complication of the reconstruction.  This will not include any secondary oncological procedures such as axillary clearance or planned procedures including exchange of expander for a fixed volume implant or lipo-modelling.  \n2. The feasibility of using mixed methods to promote shared learning and identify when the technique is sufficiently stable for evaluation in the context of an RCT will be determined by:\n2.1. The number of surgeons reporting modifications to their patient selection criteria or technique, or a post-operative complication via individual patient case report forms (CRFs). Each time one of these events occur, surgeons will be contacted and invited to take part in qualitative interviews to explore these events in further detail. The number of surgeons reporting events via CRFs and agreeing to qualitative interviews will determine the feasibility of these novel methods. \n3. The feasibility, design and conduct of a future RCT  will be determined by exploring the numbers of patients potentially eligible for pre-pectoral reconstruction; the types and frequencies of products used and approaches to concomitant interventions. This will be measured by:\n3.1. Before the study - A national practice survey of both clinical sites and individual surgeons to determine how widely pre-pectoral breast reconstruction (PPBR) is practiced and how widely the technique varies from the point of view of products used and approaches to concomitant interventions (e.g. use of surgical drains and antibiotics) at the start of the study. \n3.2. During the study - detailed screening logs will be kept at each clinical site of how many cases are suitable for implant-based breast reconstruction (IBBR), and within this group how many of those would be technically suitable for PPBR? And of those suitable for PPBR, how many go on to have the technique and if they don't choose to, their reasons. This will inform the feasibility of potentially randomising between IBBR and PPBR in a future study. \n3.3. At the close of the study - how many surgeons have taken part, what proportion have engaged with qualitative interviews. And how many surgeons report (via individual patient CRFs) that sequential operations they have performed have not been modified i.e. the procedure is stable, and can be evaluated in a randomised controlled trial. \n4. The capacity to deliver a future RCT will be determined by the success of 1, 2 and 3", "intervention": "\n\tIt is anticipated that patients entering the study will be followed up for 18 months. \n \nScreening (using SEAR method)\nScreening data will not include any patient identifiable information:\n1. All patients electing to undergo IBBR\n2. Number technically suitable for PPBR\n3. Number not considered technically suitable for PPBR and reasons for this\n4. Number accepting PPBR\n5. Number accepting study participation\n \nBaseline pre-operative assessment\n1. Patient demographic data captured\n2. BREAST-Q completed (Reconstruction-pre-operative version)\n \nSurgical admission\n1. PPBR procedure: operative data captured\n2. Length of post-operative hospital stay\n3. Post-operative pain at 24 hours or point of discharge\n4. Any immediate in-hospital complications\n \nEarly clinical follow-up\n1. Post-operative pain score at 1 and 2 weeks electronically self-reported by the patient if no longer in hospital\n2. Assessment and recording of complications at clinical review: timing as per each site’s routine standard of care follow-up arrangements\n3. Oncological data and planned adjuvant treatment (if appropriate)\n \n3-month data\n1. Assessment of complications including re-admission and re-operation if these events occur \n2. Information taken from clinical notes and in discussion with each site’s research team\n3. Pain Scores electronically self-reported by the patient at 3 months\n4. PROMs: Breast-Q reconstruction – satisfaction with information; patient reported complications\n \n18-month data\n1. BREAST-Q completed (Reconstruction-pre-operative version)\n\nAdded 23/04/2020:\nThe intervention is prepectoral implant-based breast reconstruction performed according to local surgeons’ standard practice.  \nThis is a multicentre prospective cohort study. The researchers will collect baseline demographic, operative, oncological and complication data at 3 and 18 months. Patients will complete validated patient-reported outcome questionnaires (BREAST-Q) preoperatively and at 3 and 18 months following surgery. Pain scores will be measured using a VAS at 24 hours, 1 week and 3 months.\n\tProcedure/Surgery\n\t\n\t\n      ", "condition": "\n\tBreast reconstruction\n\tSurgery\n\t\n      ", "studyDesign": "Mixed methods IDEAL 2a/2b prospective observational cohort study", "overallEndDate": "2022-09-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2025-02-26T15:37:12.229834Z", "eligibility": {"inclusion": "Consecutive women >16 who require a mastectomy for breast cancer or risk-reduction who: \n1. Elect to undergo immediate implant-based breast reconstruction\n2. Considered suitable for PPBR by their surgeon\n3. Understand and accept that PBRR is innovative and that outcome data are limited", "exclusion": "Absolute exclusion criteria:\n1. Thin/ insufficiently vascularised skin-flaps as assessed by the operating surgeon\n2. Revision /delayed breast reconstruction\n\nAdditional relative exclusion criteria applied in line with the ABS/BAPRAS guidelines for mesh-assisted breast reconstruction for surgeons in the learning phase or early practice of prepectoral breast reconstruction:\n1. Smokers or ex-smokers <6 weeks\n2. Previous radiotherapy to the ipsilateral breast/chest wall\n3. BMI >30 (except for dermal sling procedures)\n4. Implant size >600cc\n5. Anticipated post-mastectomy radiotherapy\n6. Poorly controlled diabetes", "ageRange": "Adult", "gender": "Female", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2019-05-28T00:00:00.000Z", "recruitmentEnd": "2020-12-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "341", "totalFinalEnrolment": "347"}, "countries": ["United Kingdom", "England", "Scotland", "Wales"], "locations": [{"name": "North Bristol NHS Foundation Trust", "city": "Bristol", "state": "", "country": "United Kingdom", "zip": "BS10 5NB"}, {"name": "Royal Liverpool & Broadgreen University Hospital NHS Trust", "city": "Liverpool", "state": "", "country": "United Kingdom", "zip": "L7 8XP"}, {"name": "Pennine Acute Hospitals NHS Trust (Wythenshawe)", "city": "Manchester", "state": "", "country": "United Kingdom", "zip": "M8 5RB"}, {"name": "Poole Hospitals NHS Foundation Trust", "city": "Poole", "state": "", "country": "United Kingdom", "zip": "BH15 2JB"}, {"name": "East Kent Hospitals University NHS Foundation Trust", "city": "Canterbury", "state": "", "country": "United Kingdom", "zip": "CT1 3NG"}, {"name": "Cwm Taf Morgannwg University Health Board", "city": "Pontypridd", "state": "", "country": "United Kingdom", "zip": "CF37 1LB"}, {"name": "Yeovil District Hospital NHS Foundation Trust", "city": "Yeovil", "state": "", "country": "United Kingdom", "zip": "BA21 4AT"}, {"name": "Hywel Dda University Health Board (Prince Phillip)", "city": "Carmarthen", "state": "", "country": "United Kingdom", "zip": "SA31 3BB"}, {"name": "Royal Devon & Exeter NHS Foundation Trust", "city": "Exeter", "state": "", "country": "United Kingdom", "zip": "EX2 5DW"}, {"name": "Tameside and Glossop Integrated Care NHS Foundation Trust", "city": "Ashton-Under-Lyne", "state": "", "country": "United Kingdom", "zip": "OL6 9RW"}, {"name": "Blackpool Teaching Hospitals NHS Foundation Trust", "city": "Blackpool", "state": "", "country": "United Kingdom", "zip": "FY3 8NR"}, {"name": "Hampshire Hospitals NHS Foundation Trust", "city": "Basington", "state": "", "country": "United Kingdom", "zip": "RG24 9NA"}, {"name": "Chesterfield Royal Hospital NHS Foundation Trust", "city": "Chesterfield", "state": "", "country": "United Kingdom", "zip": "S44 5BL"}, {"name": "Airedale NHS Foundation Trust", "city": "Steeton Keighley", "state": "", "country": "United Kingdom", "zip": "BD20 6TD"}, {"name": "St George's University Hospital NHS Foundation Trust", "city": "London", "state": "", "country": "United Kingdom", "zip": "SW17 0QT"}, {"name": "Nottingham University Hospitals NHS Trust", "city": "Nottingham", "state": "", "country": "United Kingdom", "zip": "NG7 2UH"}, {"name": "North Tees and Hartlepool NHS Foundation Trust", "city": "Hartlepool", "state": "", "country": "United Kingdom", "zip": "TS24 9AH"}, {"name": "Bradford Teaching Hospital NHS Foundation Trust", "city": "Bradford", "state": "", "country": "United Kingdom", "zip": "BD9 6RJ"}, {"name": "Wrightington, Wigan and Leigh NHS Foundation Trust", "city": "Wigan", "state": "", "country": "United Kingdom", "zip": "WN1 2NN"}, {"name": "Frimley Health NHS Foundation Trust (Wexham Park)", "city": "Frimley", "state": "", "country": "United Kingdom", "zip": "GU16 7UJ"}, {"name": "St Helens and Knowsley Teaching Hospitals NHS Trust", "city": "Prescot", "state": "", "country": "United Kingdom", "zip": "L35 5DR"}, {"name": "The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust", "city": "Bournemouth", "state": "", "country": "United Kingdom", "zip": "BH7 7DW"}, {"name": "Royal Berkshire NHS Foundation Trust (Reading)", "city": "Reading", "state": "", "country": "United Kingdom", "zip": "RG1 5AN"}, {"name": "Bolton NHS Foundation Trust", "city": "Bolton", "state": "", "country": "United Kingdom", "zip": "BL4 0JR"}, {"name": "The Royal Wolverhampton NHS Trust", "city": "Wolverhampton", "state": "", "country": "United Kingdom", "zip": "WV10 0QP"}, {"name": "North West Anglia NHS Foundation Trust", "city": "Peterborough", "state": "", "country": "United Kingdom", "zip": "PE3 9GZ"}, {"name": "The Oxford University Hospitals NHS Foundation Trust", "city": "Oxford", "state": "", "country": "United Kingdom", "zip": "OX3 9DU"}, {"name": "Norfolk and Norwich University Hospitals NHS Foundation Trust", "city": "Norwich", "state": "", "country": "United Kingdom", "zip": "NR4 7UY"}, {"name": "Manchester University NHS Foundation Trust", "city": "Manchester", "state": "", "country": "United Kingdom", "zip": "M13 9WL"}, {"name": "Wirral University Teaching Hospital NHS Foundation Trust", "city": "Upton", "state": "", "country": "United Kingdom", "zip": "CH49 5PE"}, {"name": "Western Sussex Hospitals NHS Foundation Trust", "city": "Worthing", "state": "", "country": "United Kingdom", "zip": "BN11 2DH"}, {"name": "Brighton & Sussex University Hospitals NHS Trust", "city": "Brighton", "state": "", "country": "United Kingdom", "zip": "BN2 5BE"}, {"name": "The Dudley Group NHS Foundation Trust", "city": "Dudley", "state": "", "country": "United Kingdom", "zip": "DY1 2HQ"}, {"name": "Leeds Teaching Hospitals NHS Trust", "city": "Leeds", "state": "", "country": "United Kingdom", "zip": "LS9 7TF"}, {"name": "East Suffolk and North Essex NHS Foundation Trust", "city": "Colchester", "state": "", "country": "United Kingdom", "zip": "CO4 5JL"}, {"name": "Grampian Health Board", "city": "Aberdeen", "state": "", "country": "United Kingdom", "zip": "AB15 6RE"}, {"name": "NHS Forth Valley", "city": "Stirling", "state": "", "country": "United Kingdom", "zip": "FK8 1DX"}], "sponsors": [{"organisation": "University of Bristol", "sponsorType": "University/education", "rorId": "https://ror.org/0524sp257"}], "funders": [{"name": "Royal College of Surgeons of England", "fundRef": "http://dx.doi.org/10.13039/501100000297"}, {"name": "The Association of Breast Surgeons"}, {"name": "The NIHR Bristol Biomedical Research Centre Director's Fund"}]}, "studySha256": "a622c15dd35afd0dad7228cbfdb986f7ee59e3c0a99a7c079486d0f9f708cb37"}