iBRA

The iBRA (implant Breast Reconstruction evAluation) study - A prospective multicentre cohort study to inform the feasibility and conduct a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction

Chief Investigator	Institution	Dates	Funding Stream	Grant Ref	Amount
Potter, Miss Shelley	University of Bristol	01/06/2015-31/05/2018 (36 months) + 6 months	NIHR Research for Patient Benefit (RfPB)	PB-PG-0214-33065	£243,418

Summary

Implant-based breast reconstruction (IBBR) is the most frequently-performed breast reconstruction operation following mastectomy (removal of the breast) for breast cancer in the UK. The standard approach involves two operations, but new techniques have recently been introduced that allow a one-stage reconstruction to be performed. While this is attractive, there is currently a lack of high-quality evidence to compare the outcomes of these procedures with the standard two-stage approach. Randomised controlled trials(RCTs) are the best way of comparing treatments but surgical RCTs are challenging and breast surgeons have not participated in multi centre breast reconstruction RCTs before.

This study will determine the feasibility of conducting a main RCT which will examine the effectiveness and cost-effectiveness of different IBBR techniques.

The study will have four phases:

Phase 1-A national practice survey

Phase 2-A 12-month prospective cohort study of consecutive patients undergoing IBBR to evaluate the clinical and patient-reported outcomes of surgery

Phase 3-An IBBR-RCT acceptability survey to explore patients' and surgeons' views of proposed trial designs and outcomes for a trial.

Phase 4-The design of the main RCT for submission for future funding.

The study will document current practice, explore potential comparators, identify relevant outcome measures, inform selection criteria, trial conduct and the size of a future trial to determine whether it is feasible. No ethical issues are anticipated.

The study will be conducted by the National Trainee Research Collaborative with the support of expert methodologists from the Liverpool Clinical Trials Research Centre and the Bristol Surgical Trials Centre.

This study will benefit patients and surgeons not only by determining trial feasibility, but also by generating the best current evidence regarding the outcomes of new approaches to IBBR. Demonstrating variations in the provision and outcomes of care will improve standardisation of practice and outcomes for future patients undergoing surgery.

Links to further information

Protocol: https://research-information.bristol.ac.uk/en/projects/nihr-rfpb-via-uh-bristol-the-ibra-implant-breast-reconstruction-evaluation-study--a-prospective-multicentre-cohort-study-to-inform-the-feasibility-and-conduct-a-pragmatic-randomised-clinical-trial-comparing-new-techniques-of-implantbased-breast-reco(2c16163d-e20d-4248-b9f1-898f0cc55ca2).html