Best-BRA
Research type
Research Study
Full title
Is subpectoral or pre-pectoral implant placement Best in immediate BReAst reconstruction?
IRAS ID
279460
Contact name
Shelley Potter
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN10081873
Duration of Study in the UK
2 years, 6 months, 5 days
Research summary
Summary of Research:
Breast cancer affects one in eight women in the UK of whom 40% will require a mastectomy as their surgical treatment. Losing a breast may affect women’s self-esteem and body image and breast reconstruction is offered to improve their quality of life. Breast reconstruction using implants is the most commonly performed procedure in the UK. There are two ways in which implants can be placed during implant-based breast reconstruction; the implants can be placed under the chest muscle (a subpectoral implant) or placed on top of the chest muscle (pre-pectoral implant).The Best-BRA external pilot study will be undertaken first to establish whether it is possible to carry out a large-scale randomised controlled trial (RCT) comparing the effectiveness and cost-effectiveness of subpectoral versus pre-pectoral implant-based breast reconstruction.
We plan to recruit women over the age of 18 who are electing to undergo immediate implant-based breast reconstruction following mastectomy for breast cancer or risk reduction. Women will be randomised to either receive pre-pectoral implant-based breast reconstruction (with or without biological or synthetic mesh) or subpectoral implant-based breast reconstruction (with or without biological or synthetic mesh).
The Outcome for Pilot phase of this study is recruitment, adherence to trial allocation and outcome completion rates with embedded QuinteT (Qualitative Research within Trials) recruitment intervention (QRI). The aim of QRI in this study is to understand the study's recruitment processes and difficulties, suggest improvements and then work with the study team to implement these. The primary outcome for main future trial is patient satisfaction with breasts at 12 months following surgery. We will follow everyone up at 3 months and 12 months.
Summary of Findings:
The Best-BRA study aimed to determine whether it would be possible to recruit patients to a large scale study comparing two types of implant-based breast reconstruction in women undergoing mastectomy.The study opened on 19/7/21 after a 20-month delay in set-up due to the COVID-19 pandemic. The average time to site opening was 310 days (range 71-557). A total of 12 UK sites were opened and 11 participants randomised over a 19-month period. The trial was closed in January 2023 due to poor recruitment. A future large-scale trial comparing pre and subpectoral IBBR in the UK was not considered feasible.
Analysis of screening logs which provide important information about patients who may be eligible to take part in the trial revealed that only 22% participants screened were considered suitable for both types of implant-based reconstruction. Furthermore, of these potentially eligible participants, only 41% were approached to take part in the study. Interview data indicated both the lower-than-expected number of eligible patients and acceptability rates were due to a rapid adoption of the newer surgical technique. This change in practice was due to surgeons’ perception that putting the implant on top of the muscle was a ‘better’ technique for patients. It was perceived as quicker and easier to perform and with improved cosmetic outcomes and less post-operative pain. The lack of high-quality evidence to support this change was acknowledged but surgeons felt the limited evidence that the newer technique was ‘no worse’, coupled with their personal experience of benefit was sufficient to change practice. This was coupled with a move away from implant reconstruction more generally due to high complication rates and poor long-term outcomes. These factors were further exacerbated by COVID-19-related delays and pressures and could not be overcome.
REC name
Wales REC 6
REC reference
20/WA/0338
Date of REC Opinion
12 Jan 2021
REC opinion
Further Information Favourable Opinion