Pre-BRA

Overview

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.

 

Aims

  • 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)

Interventions

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

N=341

Timeline

Completing recruitment: 2nd June 2020

Further information

See the ISRCTN website