Title: A mixed-methods study evaluating the feasibility of a future multi-centre randomised controlled trial comparing no-mesh to mesh-assisted breast reconstruction surgery.
Funder: Department of Health and Social Care

Abstract: Background Breast cancer impacts the lives of 55,000 women per year in the UK, 80% requiring surgery. Of these 40% require mastectomy and will be offered implant-based breast reconstruction. Since 2015, mesh has been used to provide coverage and internal support to the implant for cosmesis, driven by an industry-led marketing strategy as market authorisation of implantable devices does not require clinical evaluation. Mesh costs 2500 per breast; an estimated 26,000,000 is spent per year on breast reconstruction mesh by the NHS. There is paucity of robust high quality research with sufficient statistical precision and methodological quality to address the impact of mesh on outcomes of interest to patients, healthcare professionals and the NHS. Vaginal mesh was recently withdrawn from surgical practice recently by NHS England due to patient-reported complications. Complication rates with breast reconstruction are significant and exceed 30%, which can delay subsequent cancer treatments compromising patient outcomes. PPI discussions highlighted the profound effect of complications on quality of life and therapeutic relationships. Meta-analyses on mesh in older reconstruction techniques estimate mesh increases complications such as implant infection and loss. However studies included are low quality, uncontrolled and benefits of mesh are poorly characterised.Aim To assess the feasibility of a RCT comparing no-mesh with mesh in modern breast reconstruction surgery. Objectives1. To assess if there is surgical equipoise on the use of mesh and explore important issues for surgeons when considering RCT participation. 2. To conduct a multi-centre feasibility RCT of 40 patients across four sites, comparing no-mesh to mesh-assisted modern breast reconstruction. 3. To explore patient understanding of mesh and willingness to join and be randomised within an RCT and how to support their understanding and inclusion in trials. 4. To determine if it is possible to collect data to inform a future economic analysis on mesh in breast reconstruction. 5. To determine the acceptability of digital trial processes to healthcare professionals and patients. Wider aims Identify strategies to optimise recruitment in breast surgical trials. Develop a collaborative network for future pragmatic breast surgical trials. MethodsA mixed-methods approach will be used to address the key uncertainties outlined in the objectives: 1) Qualitative interviews of surgeons (objective 1); patients (objective 3) and study participants (objective 5). 2) Quantitative data collection on feasibility outcomes (objective 2) and clinical outcomes to inform a future economic analysis (objective 4).Training I have designed a training programme and supervisory team to complement study objectives and build my research capabilities enabling my progression to an independent academic specialising in technology evaluation in breast surgery. Anticipated impact and disseminationResults will inform a funding application to the NIHR HTA programme for a definitive RCT (subject to feasibility) to inform guidelines and practice in breast reconstructive surgery. Modern breast reconstruction without mesh is a viable alternative which may reduce patient complications and deliver substantial financial savings to the NHS. The study will produce co-created patient information on mesh in breast reconstruction. Outputs will be strategically disseminated to patients, public and NHS.

Lay abstract: BackgroundBreast cancer affects one in eight women. 55,000 women are diagnosed in the UK per year. Over 40% of women needing surgery require mastectomy and are offered breast reconstruction with an implant. Since 2015, surgeons have been using a mesh to provide additional cover and support to the implant placed on the chest wall muscles for cosmesis. Mesh costs 2500 per breast and uncertainty exists about its benefits and risks to patients. Meshes have been reported in academic literature to increase certain post-operative problems (complications) whereas the mesh industry reports benefits. The NHS spends an estimated 26,000,000 per year on mesh for breast reconstruction.As breast surgeons, we have treated patients with mesh-related complications and witnessed the impact on a patients' quality of life. These complications may require surgery to fix, and can lead to delays in giving additional cancer treatments e.g. chemotherapy. We must discuss concerns about mesh with our patients following the publicised issues with vaginal mesh complications. We do not have good quality evidence to guide patients on the risks and benefits of using mesh in breast reconstruction. Therefore, we cannot determine whether using mesh or not is better. Surgeons do have alternative techniques to using mesh but mesh is currently standard practice in the UK. If breast reconstruction is acceptable without mesh, patients may avoid complications associated with mesh use. The NHS could divert resources from mesh towards other patient needs. The best way to evaluate mesh is a randomised controlled trial (RCT) where we compare the health of the women who receive different treatments to decide which is cost-effective and safe. This type of study can be challenging and costly; currently we do not know if women and surgeons are willing to take part. Aims To carry out a feasibility trial to evaluate breast reconstruction surgery without and with mesh in patients requiring mastectomy for a definitive RCT. The specific things we want to learn about are: What surgeons think about no-mesh surgery and their willingness to participate in the study. What patients understand about mesh and their views on participating in the study. What data should be collected to help understand real-world costs to the NHS and patients of mesh in breast surgery. If using digital technology improves study feasibility. MethodsEligible patients from four hospitals will be invited to join the study. Patients will be allocated randomly to either receive breast reconstruction without mesh or with mesh. These patients will not know their treatment allocation. I aim to run the study without paper, with consent and data collection in the study via an online website. I will interview surgeons and patients to understand their views on mesh in breast reconstruction. Patients will be invited to join the study and will be interviewed about their thoughts on participation and reasons for their decision. I will gather data on patient complication rates, and whether the website was helpful in reducing the time and effort for the patients and staff involved. Patient Public Involvement and disseminationBreast surgery patients helped design the study. One output was including digital technology in study design to help patients e.g. virtual consultations and remote feedback forms. Four patients will continue to help co-creating information resources for other patients to understand mesh in breast surgery and develop methods to disseminate the results including co-authored presentations and publications. I will present the study outcomes to conferences and report findings in open-access medical journals. Social media, local media and feedback from my patient group will be used to maximise circulation of findings to patients and public including a patient designed study summary.

Research activity codes: 6.4 SURGERY
Health categories: CANCER AND NEOPLASMS