{
  "abstract": "Introduction 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’ 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.Methods and analysis 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).Ethics and dissemination 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: 301 423. 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.Trial registration numbers NCT06112977; ISRCTN17470747.",
  "authors": [
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK",
        "Medical Sociology and Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Rachel Rolph"
    },
    {
      "affiliations": [
        "Medical Sociology and Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Sue Ziebland"
    },
    {
      "affiliations": [
        "Centre for Statistics in Medicine, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Jonathan Alistair Cook"
    },
    {
      "affiliations": [
        "Health Services and Policy Research, Department of Health Sciences, University of York, York, UK"
      ],
      "name": "Cynthia Iglesias"
    },
    {
      "affiliations": [
        "School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, Portsmouth, UK"
      ],
      "name": "Joanna Wakefield-Scurr"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Charles Malyon"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Jessica Scaife"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Amy Taylor"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Aimee Hennessy"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Sarah Markham"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Marcelle Bernstein"
    },
    {
      "affiliations": [
        "Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK"
      ],
      "name": "Michael Douek"
    },
    {
      "affiliations": [],
      "name": "Restore-B Feasibility Collaborative Group"
    }
  ],
  "title": "Prepectoral no mesh versus mesh immediate implant-based reconstruction after mastectomy (Restore-B): a multicentre single-blinded randomised controlled feasibility study protocol",
  "uid": "0cae9941-5674-50cc-a389-d6df0bb7f53a"
}