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
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.
REC name
Wales REC 6
REC reference
20/WA/0338
Date of REC Opinion
12 Jan 2021
REC opinion
Further Information Favourable Opinion