A mixed-methods study evaluating the feasibility of a future multi-centre randomised controlled trial comparing no-mesh to mesh-assisted breast reconstruction surgery.

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Vaginal mesh was recently withdrawn from surgical practice recently by NHS England due to patient-reported complications.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.

Objectives 1.

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.

Methods A 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 dissemination Results 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.