Condition category
Surgery
Date applied
01/03/2019
Date assigned
08/05/2019
Last edited
05/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
55,000 women are diagnosed with breast cancer each year in the UK. 40% undergo mastectomy and of those who choose breast reconstruction, most have an implant-based operation. “Mesh” refers to a biological or plastic material which is used as a scaffold to support a breast implant during 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. The primary aim of the study is to assess the safety of this relatively novel technique of breast reconstruction. This will be established by measuring how many women in the study still have their reconstruction in place 3 months after they have had surgery. Other measures of the safety of the technique include infection rates and the number of women who have been re-admitted to hospital or undergone further surgery which was not a planned part of their reconstructive journey. It is challenging to study surgical procedures due to their complex nature; for this reason, in the past surgical research has been of poor methodological quality. As part of a broader program of work, the researchers running the Pre-Bra Study aim to set up a randomised controlled study (RCT) in breast reconstruction in the near future. RCTs provide the strongest evidence because they are the least open to bias of any study design. However, before this can be done the research team must know if:
1. Patients will accept novel/experimental surgery
2. Surgeons will take part
3. The procedure is performed in a suitably standard fashion between different hospitals and surgeons to provide meaningful comparison in a trial (RCT).

Who can participate?
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)

What does the study involve?
For patient-participants:
Patients will be asked to complete questionnaires before and after surgery. They will have an operation and see a surgeon and their team as normal following surgery. Patients will not be required to make any additional hospital visits in the study. Patients will be asked to complete post-operative pain scores at 24 hours, 48 hours, 1 week and 3 months following surgery. This may be by telephone or email depending on individual patient’s choices. We will ask patients 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. We will ask for specific consent to store your name, date of birth, address and NHS number. We would also like permission to contact patient-participants 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. The study team will also ask permission to use NHS numbers to follow up individuals via medical records without contacting you in person. Patients can agree to take part in the initial study without giving consent to be contacted about future studies.
For surgeon-participants:
The study team would like surgeons to consider participating in the shared learning aspect of the study. This may involve:
1. Completing a questionnaire about their current practice before starting patient recruitment.
2. Recording if they modify either: patient selection criteria, or the planned pre-pectoral reconstruction and reasons for these modificaitons on the electronic case report form (CRF)
3. Recording any change or modification in practice arising as a result of complications via the CRF and any learning derived from it
4. 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.

What are the possible benefits and risks of participating?
There are no benefits to individual participants, but the information collected during the study might help women make choices regarding breast reconstruction in future. There are no risks involved in trial participation beyond the inherent risks of surgery, which will be explained by individual surgeons and are independent of the study.

Where is the study run from?
University of Bristol (UK)

When is the study starting and how long is it expected to run for?
October 2017 to April 2021 - recruiting from June 2019 to June 2020

Who is funding the study?
The Royal College of Surgeons of England, The Association of Breast Surgeons, The Bristol BRC

Who is the main contact?
Kate Harvey, postgraduate researcher and breast surgeon
kate.harvey@bristol.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Kate Harvey

ORCID ID

http://orcid.org/0000-0002-7199-0238

Contact details

Centre for Surgical Research
Bristol Medical School
Canynge Hall
Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 (0)117 928 9000
kate.harvey@bristol.ac.uk

Type

Scientific

Additional contact

Miss Kate Harvey

ORCID ID

http://orcid.org/0000-0002-7199-0238

Contact details

Centre for Surgical Research
Bristol Medical School
Canynge Hall
Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 (0)117 928 9000
kate.harvey@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.0

Study information

Scientific title

The Pre-pectoral Breast reconstruction 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

Acronym

Pre-Bra

Study hypothesis

Pre-Pectoral breast reconstruction is safe and results in levels of pain and implant animation following surgery which are acceptable to patients.

Ethics approval

Approved 10/05/2019, NHS HRA South Central - Oxford B Research Ethics Committee (Whitefriars, Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT; 0207 104 8168; nrescommittee.southcentral-oxfordb@nhs.net), ref: 19/SC/0129

Study design

Mixed methods IDEAL 2a/2b prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request participant information sheet

Condition

Breast reconstruction

Intervention

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

Screening (Using SEAR method)
Screening data will not include any patient identifiable information:
1. All patients electing to undergo IBBR
2. Number technically suitable for PPBR
3. Number not considered technically suitable for PPBR and reasons for this
4. Number accepting PPBR
5. Number accepting study participation

Baseline Pre-Operative Assessment
1. Patient demographic data captured
2. BREAST-Q completed (Reconstruction-pre-operative version)

Surgical Admission
1. PPBR procedure: operative data captured
2. Length of post-operative hospital stay
3. Post-operative pain at 24 hours or point of discharge
4. Any immediate in-hospital complications

Early clinical follow-up
1. Post-operative pain score at 1 and 2 weeks electronically self-reported by the patient if no longer in hospital
2. Assessment and recording of complications at clinical review: timing as per each site’s routine standard of care follow-up arrangements
3. Oncological data and planned adjuvant treatment (if appropriate)

3-month Data
1. Assessment of complications including re-admission and re-operation if these events occur
2. Information taken from clinical notes and in discussion with each site’s research team
3. Pain Scores electronically self-reported by the patient at 3 months
4. PROMs: Breast-Q reconstruction – satisfaction with information; patient reported complications

18-month Data
1. BREAST-Q completed (Reconstruction-pre-operative version)

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Implant loss rate at 3 months will be determined by clinical review carried out by participating surgeons at participating clinical sites. Implant loss is defined as: "any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery.".

Secondary outcome measures

1. Safety will be determined by comparing key safety outcomes for pre-pectoral breast reconstruction including infection; return to theatre and readmission at 3 months with published national audit data. All 3 measures will be determined by clinical teams and reported to the central study team as they occur. Definitions of all 3 measures are:
1.1. Infection- A hot, red swollen breast associated with one of the following; a temperature, pus at the wound site, a raised white cell count and/or; a positive wound swab within the first 3 months following surgery. This will be further classified as:
1.1.1. Minor – requiring oral antibiotics only;
1.1.2. Major 1 – requiring admission for IV antibiotics and/or debridement;
1.1.3. Major 2 – requiring surgical drainage/debridement
1.2. Readmission to hospital– any re-admission to hospital in the 3 months following surgery directly related to the procedure (e.g. with infection requiring antibiotics).
1.3. Return to theatre – Return to the operating theatre at any time during the first 3 months following surgery to deal with any complication of the reconstruction. This will not include any secondary oncological procedures such as axillary clearance or planned procedures including exchange of expander for a fixed volume implant or lipo-modelling.
2. The feasibility of using mixed methods to promote shared learning and identify when the technique is sufficiently stable for evaluation in the context of an RCT will be determined by:
2.1. The number of surgeons reporting modifications to their patient selection criteria or technique, or a post-operative complication via individual patient case report forms (CRFs). Each time one of these events occur, surgeons will be contacted and invited to take part in qualitative interviews to explore these events in further detail. The number of surgeons reporting events via CRFs and agreeing to qualitative interviews will determine the feasibility of these novel methods.
3. The feasibility, design and conduct of a future RCT will be determined by exploring the numbers of patients potentially eligible for pre-pectoral reconstruction; the types and frequencies of products used and approaches to concomitant interventions. This will be measured by:
3.1. Before the study - A national practice survey of both clinical sites and individual surgeons to determine how widely pre-pectoral breast reconstruction (PPBR) is practiced and how widely the technique varies from the point of view of products used and approaches to concomitant interventions (e.g. use of surgical drains and antibiotics) at the start of the study.
3.2. During the study - detailed screening logs will be kept at each clinical site of how many cases are suitable for implant-based breast reconstruction (IBBR), and within this group how many of those would be technically suitable for PPBR? And of those suitable for PPBR, how many go on to have the technique and if they don't choose to, their reasons. This will inform the feasibility of potentially randomising between IBBR and PPBR in a future study.
3.3. At the close of the study - how many surgeons have taken part, what proportion have engaged with qualitative interviews. And how many surgeons report (via individual patient CRFs) that sequential operations they have performed have not been modified i.e. the procedure is stable, and can be evaluated in a randomised controlled trial.
4. The capacity to deliver a future RCT will be determined by the success of 1, 2 and 3

Overall trial start date

01/10/2017

Overall trial end date

01/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Consecutive women >16 who require a mastectomy for breast cancer or risk-reduction who:
1. Elect to undergo immediate implant-based breast reconstruction
2. Considered suitable for PPBR by their surgeon
3. Understand and accept that PBRR is innovative and that outcome data are limited

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

341

Participant exclusion criteria

Absolute exclusion criteria:
1. Thin/ insufficiently vascularised skin-flaps as assessed by the operating surgeon
2. Revision /delayed breast reconstruction

Additional relative exclusion criteria applied in line with the ABS/BAPRAS guidelines for mesh-assisted breast reconstruction for surgeons in the learning phase or early practice of PPBR:
1. Smokers or ex-smokers <6 weeks
2. Previous radiotherapy to the ipsilateral breast/chest wall
3. BMI >30 (except for dermal sling procedures)
4. Implant size >600cc
5. Anticipated post-mastectomy radiotherapy
6. Poorly controlled diabetes

Recruitment start date

03/06/2019

Recruitment end date

02/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Southmead Rd Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

The University of Bristol

Sponsor details

Senate House
Tyndall Ave
Bristol
BS8 1TH
United Kingdom
+44 (0)1174284011
anna.brooke@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bristol.ac.uk/homepage/

Funders

Funder type

Other

Funder name

Royal College of Surgeons of England

Alternative name(s)

RCS

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Funder name

The Association of Breast Surgeons

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Bristol Biomedical Research Centre Director's Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The Pre-Bra Study’s methodology and results will be published and presented at national and international meetings and in a peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: The ethics approval was added. 07/06/2019: Internal review. 10/05/2019: Internal review.