The PRE-BRA study is an evaluation feasibility study; a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant-based breast reconstruction

Sub-pectoral implant-based reconstruction, placing a breast implant and mesh underneath the chest wall muscle, has become standard despite a lack of evidence to support its use.

A new technique has developed in which a breast implant is completely covered in mesh and placed in front of the chest-wall muscle rather than underneath. This may result in less pain and more natural results, but this has yet to be established. However, pre-pectoral breast reconstruction (PPBR) is already being performed and is gaining popularity. There is a need to robustly evaluate this technique before it becomes standard.



  • to assess the safety of this relatively novel technique of breast reconstruction. including infection rates and the number of women who have been re-admitted to hospital or undergone further surgery
  • to set up a randomised controlled study (RCT) in breast reconstruction in the near future.

Inclusion Criteria:

Women aged over 16 undergoing mastectomy and reconstruction (either for breast cancer or risk reduction) using breast implants placed in the pre-pectoral position (pre-pectoral breast reconstruction)


It is anticipated that patients entering the study will be followed up for 18 months.

For patient-participants:

  • Patients will be asked to complete questionnaires before and after surgery.
  • Patients will be asked to complete post-operative pain scores at 24 hours, 48 hours, 1 week and 3 months following surgery.
  • Patients will be asked to complete questionnaires at 3 and 18 months to assess how satisfied they are with the outcomes of surgery and whether they have experienced any problems.
  • Patients will be asked for permission to be contacted in future. This may be for a follow on study to look at the long-term outcomes of this type of reconstruction and we may ask patients to complete another questionnaire.

For surgeon-participants:

The study team would like surgeons to consider participating in the shared learning aspect of the study. This may involve:

  • Completing a questionnaire about their current practice before starting patient recruitment.
  • Recording if they modify either: patient selection criteria, or the planned pre-pectoral reconstruction and reasons for these modifications on the electronic case report form (CRF)
  • Recording any change or modification in practice arising as a result of complications via the CRF and any learning derived from it
  • Agreeing to be interviewed to discuss their responses to 1, 2 or 3

If surgeons agree to participate in an interview, they will be conducted by telephone at a convenient time. Interviews will be brief and will take no more than 20 minutes.

Planned Sample Size:



Completing recruitment: 2nd June 2020

Further information:

See the ISRCTN website