{"registry": "ISRCTN", "registryId": "ISRCTN10081873", "source": "https://www.isrctn.com/ISRCTN10081873", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN10081873/format/default", "fetchedAt": "2026-10-07T17:00:22.625681Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Is implant placement under or above the chest muscle best in immediate breast reconstruction?", "scientificTitle": "Is subpectoral or pre-pectoral implant placement Best in immediate BReAst reconstruction? The Best-BRA Pilot Trial", "acronym": "Best-BRA pilot", "hypothesis": "Pre-pectoral implant based breast reconstruction (IBBR), a ‘muscle sparing’ technique which involves the wrapping of the implant in mesh and placing it on top rather than underneath the pectoralis muscle may improve patient outcome compared to subpectoral (under the muscle) IBBR and it is becoming increasingly popular. There is however, a lack of high-quality evidence to support the effectiveness of either of these techniques. Before a large-scale trial is conducted, we first need to address whether surgeons will recruit patients to a randomised study comparing two approaches to IBBR and whether patients will consent to be randomised and agree to receive their allocated treatment.", "primaryOutcome": "Assessed throughout the duration of the trial using screening logs:\n1. Recruitment into trial (number of sites recruiting; proportion of eligible women approached that are randomised, women recruited per site per month)\n2. Adherence to trial allocation by comparing number of women allocated to trial intervention vs. their actual reconstruction (i.e pre-pec or subpectoral IBBR)\n3. Completion rates measured by overall data completeness (% missing data)", "secondaryOutcome": "1. Satisfaction with breasts using the validated BREAST-Q questionnaire at 12 months\n2. Surgical complications, in particular implant loss, infection, re-admission and reoperation measured using patient records at 3 and 12 months\n3. Need for additional surgery to the reconstruction or the contralateral breast measured using patient records at 12 months\n4. Pain scores assessed using a visual analogue scale (VAS) at 24 hours and 1 week\n5. Objective cosmetic outcome at 12 months assessed using routinely collected patient photographs \n6. EQ-5D-5L health-related quality of life score at 12 months\n7. Wellbeing (ICECAP-A) score at 12 months\n8. Patient-reported outcome domains included in the breast reconstruction core outcome set including physical well-being (chest); emotional well-being; and animation assessed using appropriate subscales of the BREAST-Q at 12 months\n9. Cost-effectiveness of pre-pectoral and subpectoral IBBR assessed by micro-costing the two procedures. Data will be gathered from electronic notes/medical records as well as routine data", "intervention": "\n\tWomen who require a mastectomy for either breast cancer or risk reduction and elect to have an IBRR will be recruited and randomised 1:1 for either a subpectoral or pre-pectoral implant reconstruction with mesh. Patients will then receive standard care as per clinical guidelines and be followed-up for 12 months.\n\nA QRI will be used to identify recruitment challenges and optimise recruitment to the trial. Best-BRA will assess the feasibility of a future, multi-centre randomised controlled trial to determine the most clinically effective and most cost-effective IBBR technique.\n\nRandomisation- The randomisation sequence will be generated by the Bristol Medical School’s REDCap database randomisation system. Participants will only be randomised after eligibility and consent have been confirmed. Patients will be randomly allocated to the techniques in a 1:1 ratio stratified by hospital. Randomisation within blocks of varying size will prevent large imbalances in the number of patients in each treatment arm. Randomisation will occur at the final clinic visit prior to admission for surgery. Access to the allocation will be by a web-based system and the allocation will be concealed until the patient has been logged into the system and a study ID number generated so ensuring that judgements about eligibility are made without knowledge of the next allocation (allocation concealment). The unit of randomisation will be the patient. Those women having bilateral mastectomy and IBBR will have the same procedure on each side (i.e. either pre-pectoral or subpectoral) within the study. The surgeon will be informed of the patient’s treatment allocation following randomisation to allow them to plan theatre lists and ensure sufficient operating time is available.\n\tProcedure/Surgery\n\t\n\t\n      ", "condition": "\n\tImplant-based breast reconstruction following mastectomy for breast cancer or risk reduction\n\tSurgery\n\t\n      ", "studyDesign": "Pragmatic two-arm external pilot randomised controlled trial with QuinteT Recruitment Intervention (QRI) and economic scoping", "overallEndDate": "2023-08-31T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2025-08-05T08:28:03.770929615Z", "eligibility": {"inclusion": "1. Aged 18 years or above\n2. Require a mastectomy for breast cancer or risk-reduction\n3. Elect to undergo immediate IBBR\n4. Considered eligible for either pre or subpectoral reconstruction by the surgical team", "exclusion": "1. Had a delayed reconstruction\n2. Has had revision breast reconstruction surgery", "ageRange": "Adult", "gender": "Female", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2021-07-26T00:00:00.000Z", "recruitmentEnd": "2023-01-31T00:00:00.000Z", "recruitmentStatusOverride": "Stopped", "recruitmentStartStatusOverride": "", "targetEnrolment": "100", "totalFinalEnrolment": "11"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "Southmead Hospital", "city": "Bristol", "state": "", "country": "United Kingdom", "zip": "BS10 5NB"}, {"name": "Hemel Hempstead Hospital", "city": "Hemel Hempstead", "state": "", "country": "United Kingdom", "zip": "HP2 4AD"}, {"name": "University Hospitals Coventry and Warwickshire NHS Trust", "city": "Coventry", "state": "", "country": "United Kingdom", "zip": "CV6 6NY"}], "sponsors": [{"organisation": "North Bristol NHS Trust", "sponsorType": "Hospital/treatment centre", "rorId": "https://ror.org/036x6gt55"}], "funders": [{"name": "National Institute for Health Research", "fundRef": "http://dx.doi.org/10.13039/501100000272"}, {"name": "NIHR Academy; Grant Codes: CS-2016-16-019"}]}, "studySha256": "b9aa04b176fbda047f91f659350b13febeabdb0da9b889077b2b305bbff7a3e0"}