TeaM


UPDATE: 19/07/2017

Recruitment closed on 30th June 2017.  Final data entry is underway.  There are currently 729 records in the system.  Well done to everyone involved!

Certificates will be issue to collaborators once the final data have been verified during autumn 2017.


UPDATE: 21/11/2016

Elizabeth Baker presented an update at the iBRA3 Study Day.

46 centres are participating. To date 37 patients have been entered into REDCap.

Recruitment will continue to the end of February. Units can still join the study.


Background

Breast conserving surgery (BCS) and adjuvant radiotherapy is an established treatment for early breast cancer. While many women may prefer breast conservation to mastectomy, in many cases, standard BCS may result in unacceptable cosmetic outcomes which may adversely impact on patient satisfaction and quality of life. Therapeutic mammaplasty (TM) describes ‘the oncoplastic application of breast reduction and mastopexy techniques to treat selected breast cancers by breast conserving surgery (BCS)’. These techniques effectively extend the boundaries of traditional BCS by allowing adequate resection of larger tumours in women with medium to large breasts without compromising cosmetic outcome; provide an alternative to mastectomy +/- reconstruction in those with ptotic breasts and may improve outcomes for women with large breasts in whom standard BCS followed by radiotherapy may be associated with lymphoedoema, fibrosis and chronic pain.

Despite the widespread adoption of these techniques into routine practice, there is limited high-quality evidence to support benefits of this approach. TM procedures are more complex than standard BCS with significant associated resource implications and concerns have been raised regarding both complication rates and oncological safety when TM is performed. Although these concerns are not supported by the literature, the majority of published studies are small, retrospective single centre, often single surgeon case series with limited follow-up that are poorly designed and reported with inconsistent end-points that limit cross-study comparison such that the findings cannot be relied upon. Two recent systematic reviews have highlighted the paucity of high-quality clinical, oncological and cosmetic outcome data and emphasised the urgent need for well-designed prospective studies to establish the indications and outcomes of therapeutic mammaplasty to determine best practice. Uncertainties relating to the current indications for TM including the practice and outcomes of TM in large tumours (>4cm) not traditional managed by BCS; rates and management of margin positivity; predictors of adverse outcomes; the impact of TM on delivery of adjuvant therapy and appropriate assessment of key patient reported outcomes including, but not limited to, aesthetic end-points, as well as long term data on recurrence rates in particular need to be addressed if the procedure is to be offered and bench-marked appropriately.

Although RCTs provide the best evidence for the effectiveness of an intervention, trials are largely inappropriate in this context. A high-quality prospective multicentre cohort study exploring the practice and outcomes of these techniques is therefore essential to support the safe practice of TM, generate guidelines, guide decision-making and inform health policy.

Aims and objectives

i. To identify the number of units performing TM across the UK and the volumes of procedures performed
ii. To describe the current practice of therapeutic mammaplasty (TM) including the indications and techniques used
iii. To evaluate the clinical outcomes of TM using different techniques and explore predictors of adverse outcome.
iv. To determine the impact of TM on the delivery of adjuvant therapy
v. To determine best practice with regards to TM with a view to generating national guidelines
vi. To establish a network of units performing TM willing and able to participate in future research studies
vii. To inform the feasibility, design and conduct of a prospective multicentre cohort study exploring the clinical, patient-reported and oncological outcomes of TM.

How do I get involved?

TeaM is now recruiting units. If you would like to be a collaborator, complete the form below and the team will get in touch. Anais Rosich-Medina is the RSTN Trainee Lead for the project.

The table at the bottom shows a live update of the units involved with the current collaborators.

Any questions? Contact mfacteamstudy@gmail.com.


  • Protocol development
  • NRES approval
  • Data collection
  • Data analysis
  • Manuscript submission
  • Publication
Miss Elizabeth Baker
ST8 Breast Surgery

Mr Olivier Branford
Consultant Plastic Surgeon
Royal Marsden NHS Foundation Trust

Miss Lisa Brock
Research Co-ordinator
Nottingham Breast Institute

Ms Patricia Fairbrother
Independent Cancer Patients’ Voice
Patient Representative

Miss Charlotte Ives
ST8, Breast Surgery
Penninsula Deanery

Professor Chris Holcombe
Professor of Breast Surgery
Royal Liverpool Hospital
ABS Academic and Research Committee Representative

Mr Abhilash Jain
RCS SSL in Plastic and Hand Surgery

Mr Baek Kim
ST6 Breast trainee
Yorkshire and the Humber Deanery

Mr R Douglas Macmillan
Consultant Oncoplastic Breast Surgeon
Nottingham Breast Institute

Mr John Murphy
Consultant Oncoplastic Breast Surgeon
University Hospital South Manchester

Miss Shelley Potter
Academic Clinical Lecturer
University of Bristol

Mr Tim Rattay
NIHR Doctoral Fellow
University of Leicester

Mr Dennis Remoundos
Consultant Oncoplastic Breast Surgeon
Oxford

Mr Richard Sutton
Consultant Oncoplastic Breast Surgeon
Royal United Hospital Bath

Mr Adam Trickey
Research Associate
School of Social and Community Medicine, University of Bristol
Statistician and methodology

Miss Kate Williams
National Oncoplastic Fellow
President, Mammary Fold
University Hospitals South Manchester

Collaborators will be listed here in due course.
Bristol Surgical Trials Centre
Funding applied for from ABS.