The LiBRA (Loss of implant breast reconstruction evaluation) study.
Research type
Research Study
Full title
A mixed methods study to explore the experiences and outcomes of women experiencing implant loss following immediate implant-based breast reconstruction
IRAS ID
203112
Contact name
Shelley Potter
Contact email
Sponsor organisation
University of Bristol
Clinicaltrials.gov Identifier
researchregistry1002, Research Registry Website
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Breast cancer affects over 51,000 women each year, of whom up to 40% will require a mastectomy as the primary surgical treatment for their disease. Implant based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. Traditionally a 2 stage procedure suitable for women with small to medium sized breasts, the introduction of new techniques for implant coverage have broadened the indications for the procedure and may allow single stage reconstruction. \n\nAlthough IBBR can produce excellent results, up to 10% of patients may experience the loss of their implant which can be devastating for both the patient and surgeon. Although rates of implant loss are commonly reported in the literature is not clear what happens to women who lose their implant, if and when they have further reconstructive surgery, what types of procedure they choose, what influences their decisions and how this process influences their quality of life. \n\nThe aim of the LiBRA study is to use qualitative and quantitative methods to better understand the process of care of patients who lose an implant following IBBR, as well as explore their experiences of the event. It is anticipated that this research will provide better information for these patients regarding their potential management pathway and what they may expect, as well as identify best practice guidance for potential integration into national practice. \n\nThis is a mixed methods study in two phases, the first phase consisting of qualitative interviews, followed by a subsequent quantitative questionnaire phase. The rich, in-depth information collected during the interviews will be used to develop the study questionnaire. Therefore, study documentation is included in this ethics application for the interview phase, and a substantial amendment will be submitted with the questionnaire documents at a later stage.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0115
Date of REC Opinion
11 May 2016
REC opinion
Favourable Opinion