Restore-B
Research type
Research Study
Full 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 (Restore-B).
IRAS ID
301423
Contact name
Rachel Rolph
Contact email
Sponsor organisation
University of Oxford/Research Governance, Ethics & Assurance Team
Duration of Study in the UK
6 years, 3 months, 1 days
Research summary
Breast cancer affects one in eight women. Over 40% of women needing surgery require mastectomy and are offered breast reconstruction with an implant. Since 2015, surgeons have been using mesh to provide additional cover and support to the implant on the chest wall. Mesh costs £2500 and uncertainty exists about its benefits and risks to patients. Meshes have been reported to increase post-operative problems whereas the mesh industry reports benefits. We must discuss concerns about mesh following publicised issues with vaginal mesh. We do not have good quality evidence to guide patients on the risks and benefits of using mesh in breast reconstruction.
The best way to evaluate mesh is a randomised controlled trial 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.
Aim:To carry out a feasibility trial to evaluate breast reconstruction surgery without and with mesh in patients requiring mastectomy for a future definitive trial.
The specific things we want to learn 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 are the estimated costs of mesh?Methods:
Eligible patients will be invited to join the study if they are due to have this operation. Participants will be randomly allocated at surgery to receive mesh or not. These patients will not know their allocation. They will be followed up with routine NHS standard of care. We will collect additional information on their quality of life in the two groups and access to healthcare services post operatively. We will interview participants and surgeons.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0302
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion