{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T00:15:02Z","timestamp":1793664902903,"version":"4.5.1"},"reference-count":19,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000},"content-version":"unspecified","delay-in-days":16,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Institute for Health and Care Research, UK","award":["NIHR302349"],"award-info":[{"award-number":["NIHR302349"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,7,11]]},"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients\u2019 own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23\/SC\/0302; IRAS Project ID: 301\u2009423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration numbers<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06112977\">NCT06112977<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN17470747\">ISRCTN17470747<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-103278","type":"journal-article","created":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T11:15:44Z","timestamp":1760699744000},"page":"e103278","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Prepectoral no mesh versus mesh immediate implant-based reconstruction after mastectomy (Restore-B): a multicentre single-blinded randomised controlled feasibility study protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06112977","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"isrctn17470747","registry":"10.18810\/isrctn"},{"clinical-trial-number":"nct06112977","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"isrctn17470747","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-8713-9573","authenticated-orcid":false,"given":"Rachel","family":"Rolph","sequence":"first","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"},{"name":"Medical Sociology and Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue","family":"Ziebland","sequence":"additional","affiliation":[{"name":"Medical Sociology and Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4156-6989","authenticated-orcid":false,"given":"Jonathan Alistair","family":"Cook","sequence":"additional","affiliation":[{"name":"Centre for Statistics in Medicine, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3426-0930","authenticated-orcid":false,"given":"Cynthia","family":"Iglesias","sequence":"additional","affiliation":[{"name":"Health Services and Policy Research, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Wakefield-Scurr","sequence":"additional","affiliation":[{"name":"School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, Portsmouth, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Malyon","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Scaife","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Taylor","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aimee","family":"Hennessy","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Markham","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelle","family":"Bernstein","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Douek","sequence":"additional","affiliation":[{"name":"Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,10,17]]},"reference":[{"key":"2025120415070850000_15.10.e103278.1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"2025120415070850000_15.10.e103278.2","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1001\/jamasurg.2014.2895","article-title":"Nationwide trends in mastectomy for early-stage breast cancer","volume":"150","author":"Kummerow","year":"2015","journal-title":"JAMA Surg"},{"key":"2025120415070850000_15.10.e103278.3","doi-asserted-by":"crossref","first-page":"720","DOI":"10.12968\/hmed.2019.80.12.720","article-title":"Genetics of breast cancer: management strategies and risk-reducing surgery","volume":"80","author":"Balasubramanian","year":"2019","journal-title":"Br J Hosp Med"},{"key":"2025120415070850000_15.10.e103278.4","doi-asserted-by":"crossref","first-page":"344","DOI":"10.1016\/j.clbc.2020.11.013","article-title":"Quality of life and early functional evaluation in direct-to-implant breast reconstruction after mastectomy: a comparative study between prepectoral versus dual-plane reconstruction","volume":"21","author":"Caputo","year":"2021","journal-title":"Clin Breast Cancer"},{"key":"2025120415070850000_15.10.e103278.5","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1093\/bjs\/znac077","article-title":"Short-term safety outcomes of mastectomy and immediate prepectoral implant-based breast reconstruction: Pre-BRA prospective multicentre cohort study","volume":"109","author":"Harvey","year":"2022","journal-title":"Br J Surg"},{"key":"2025120415070850000_15.10.e103278.6","unstructured":"The cumberlege review. 2020. Available: https:\/\/www.immdsreview.org.uk\/downloads\/IMMDSReview_Web.pdf"},{"key":"2025120415070850000_15.10.e103278.7","doi-asserted-by":"crossref","first-page":"973","DOI":"10.1097\/PRS.0000000000009618","article-title":"Prepectoral direct-to-implant breast reconstruction without placement of acellular dermal matrix or mesh after nipple-sparing mastectomy","volume":"150","author":"Urban","year":"2022","journal-title":"Plast Reconstr Surg"},{"key":"2025120415070850000_15.10.e103278.8","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30781-2"},{"key":"2025120415070850000_15.10.e103278.9","doi-asserted-by":"publisher","DOI":"10.1097\/SAP.0b013e31823f3cd9"},{"key":"2025120415070850000_15.10.e103278.10","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1038\/s41416-019-0438-1","article-title":"The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study","volume":"120","author":"O\u2019Connell","year":"2019","journal-title":"Br J Cancer"},{"key":"2025120415070850000_15.10.e103278.11","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/0360-3016(79)90729-6","article-title":"Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast","volume":"5","author":"Harris","year":"1979","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"2025120415070850000_15.10.e103278.12","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2929.2006.02467.x"},{"key":"2025120415070850000_15.10.e103278.13","doi-asserted-by":"publisher","DOI":"10.1080\/2000656X.2017.1419141"},{"key":"2025120415070850000_15.10.e103278.14","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0b013e3182361fd6"},{"key":"2025120415070850000_15.10.e103278.15","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)30668-4"},{"key":"2025120415070850000_15.10.e103278.16","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000003054"},{"key":"2025120415070850000_15.10.e103278.17","doi-asserted-by":"crossref","unstructured":"Singla A , Singla A , Lai E , et al . Subcutaneously placed breast implants after a skin-sparing mastectomy: do we always need ADM? Plast Reconstr Surg Glob Open 2017;5. doi:10.1097\/GOX.0000000000001371","DOI":"10.1097\/GOX.0000000000001371"},{"key":"2025120415070850000_15.10.e103278.18","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.9804"},{"key":"2025120415070850000_15.10.e103278.19","doi-asserted-by":"crossref","first-page":"e521","DOI":"10.1016\/S1470-2045(18)30511-4","article-title":"Opportunities and priorities for breast surgical research","volume":"19","author":"Cutress","year":"2018","journal-title":"Lancet Oncol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-103278","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T23:11:10Z","timestamp":1764889870000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-103278"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":19,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2025,10,17]]},"published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1136\/bmjopen-2025-103278"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-103278","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]}}}