Overview
Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. Techniques have evolved with the introduction of mesh-assisted single stage direct to implant reconstruction and most recently pre-pectoral techniques. However, there is no high-quality evidence to support best practice which means some women may not be getting the best treatment.
The iBRA prospective cohort study demonstrated that there is no difference in short-term safety outcomes at 3 months or patient-reported outcomes at 18 months between different types of implant-based reconstruction with or without mesh.
The iBRA randomisation acceptability study suggested that a well-designed randomised trial in implant-based reconstruction may be feasible. The area of greatest uncertainty among breast and plastic surgeons was whether the implant should be placed under (subpectoral) or on top of the muscle (pre-pectoral).
In response to the lack of reliable evidence on implant-based reconstruction and findings from the iBRA study we have designed the Best-BRA study - a pilot randomised controlled trial (RCT) to determine whether it is possible to recruit patients to a study comparing subpectoral and pre-pectoral reconstruction techniques. If the pilot study shows that it is feasible, we plan to roll the pilot into a large-scale RCT. A well-designed, adequately powered RCT to evaluate the clinical and cost-effectiveness of sub- or pre-pectoral implant-based breast reconstruction techniques will enable future practice to be driven by robust and reliable evidence meaning women will get the best treatment.
As randomised clinical trials in surgery can be challenging, Best-BRA will include in the pilot phase an embedded QuinteT Recruitment Intervention to support sites with recruitment. Recruiters will be offered feedback and strategies on how best to explain the study, convey equipoise and engage with patients’ concerns.
We would like to invite pilot sites to join the study. Pilot sites can be breast or plastic surgery units that routinely offer patients pre and subpectoral implant-based breast reconstruction. We would expect sites to recruit up to 10 patients per year.
Objectives
The objectives of the Best-BRA pilot study are to:
- Establish if it is possible to recruit patients to an RCT comparing two approaches to IBBR by recording the number and proportion of women electing to undergo IBBR who are potentially eligible, consent to randomisation and accept their allocated treatment.
- To undertake a QuinteT Recruitment Intervention (QRI) to identify recruitment challenges and optimise recruitment to the trial.
- Pilot the collection of the candidate primary outcome(s) identified in the iBRA study and the recently developed Core Measurement Set (CMS) for implant-based breast reconstruction.
- Determine the feasibility of collecting resource-use using the recently proposed targeted micro-costing framework for efficient use of micro-costing in surgical studies.
Inclusion/ exclusion criteria
Women must:
- Be aged 18 years or above
- Require a mastectomy for breast cancer or risk-reduction
- Elect to undergo immediate IBBR
- Considered eligible for both pre or subpectoral reconstruction by the surgical team
Exclusion criteria are:
- Delayed reconstruction
- Patients having revision breast reconstruction surgery
Planned sample size
A formal sample size calculation is not required as this is an external pilot study. During this pilot phase, the aim is to review recruitment (number of sites recruiting; proportion of eligible women that are approached and randomised, women recruited per site per month), adherence to trial allocation and outcomes completion rates will be reviewed at 12 months. At 12 months the parameters required for a fully powered trial will also be determined (number of sites and sample size) to inform the feasibility of undertaking a definitive RCT.
Total number of sites planned
25
Timeline
Recruitment to start July 2021 for 12 months. There will be a 12-month follow-up therefore study end date is estimated as being in July 2023.
Best-BRA is now closed.
Contact information and website:
Ms Shelley Potter (Best-BRA CI and Associate Professor, University of Bristol).
E-mail: shelley.potter@bristol.ac.uk