1. The TeaM (Therapeutic Mammaplasty) study: Protocol for a prospective multi-centre cohort study to evaluate the practice and outcomes of therapeutic mammaplasty
- Author
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Rajgopal Achuthan, Kathryn Williams, Lisa Brock, Gardiner, Adam Trickey, Baek Kim, Tim Rattay, Philip Turton, Richard Sutton, Shelley Potter, Abhilash Jain, Charlotte Ives, Patricia Fairbrother, Naren Basu, Dennis Remoundos, Elizabeth A. Baker, Shweta Aggarwal, R. Douglas Macmillan, John Murphy, and Chris Holcombe
- Subjects
therapeutic mammaplasty ,Reconstructive surgery ,medicine.medical_specialty ,Complications ,medicine.medical_treatment ,Breast surgery ,trainee collaboratives ,Adjuvant therapy ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Protocol ,Medicine ,030212 general & internal medicine ,Trainee collaboratives ,COMPLICATIONS ,business.industry ,General surgery ,Wide local excision ,adjuvant therapy ,medicine.disease ,Surgery ,Centre for Surgical Research ,Therapeutic mammaplasty ,030220 oncology & carcinogenesis ,Mammaplasty ,Breast reduction ,business ,Cohort study ,Mastectomy - Abstract
Highlights • Multicentre prospective study involving breast and plastic surgical units across the UK. • Will produce valuable data regarding the practice and outcomes of therapeutic mammaplasty. • Will inform decision-making and lead to future definitive study. • Will strengthen the collaborative network to facilitate the delivery of future projects. • Will increase awareness of the techniques among trainees such that participation is educational., Introduction Wide local excision and adjuvant radiotherapy is the standard of care for early breast cancer. For large tumours, however, mastectomy is frequently recommended as conventional breast-conserving techniques often result in poor cosmetic outcomes. Therapeutic mammaplasty (TM) may extend the boundaries of breast-conserving surgery by combining breast reduction and mastopexy techniques with tumour excision, preserving a natural breast shape and avoiding the need for mastectomy. The prevalence of this operative option among surgeons in the UK and its success rate are unknown. The TeaM study is a multicentre prospective study that aims to investigate the practice and outcomes of TM. Methods and analysis Breast centres performing TM will be invited to participate through the research collaborative network and the professional associations. All patients undergoing TM between September 2016 and March 2017 will be included. Demographic, operative, oncological and complication data within 30-days of surgery will be collected. The primary outcome will be unplanned re-operation for complications. Secondary outcomes will include unplanned readmission, re-excision rates and time to adjuvant therapy. Prospective data on 500 patients from 50 centres are anticipated. Exploratory analyses will identify predictors for complications and inform the design of a definitive study. Ethics and dissemination Research ethics approval is not required for this study. This has been confirmed by the on-line Health Research Authority decision tool. This study will provide novel information regarding the practice and outcomes of TM in the UK. This will inform decision-making for patients and surgeons and inform future research. Dissemination of the study protocol will be via the Mammary Fold Academic and Research Collaborative, the Reconstructive Surgery Trials Network and the professional associations, the Association of Breast Surgery and British Association of Plastic, Reconstructive and Aesthetic Surgeons. Results will be presented at relevant surgical conferences and published in peer-reviewed journals.
- Published
- 2016
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