The Pre-pectoral Breast Reconstruction Evaluation Feasibility Study - a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant-based breast reconstruction

niversity of Bristol0 个研究点目标入组 347 人开始时间: 2019年5月8日最近更新: 2023年8月2日

适应症

试验速览

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31988232 protocol (added 09/04/2020) 2022 Results article in https://doi.org/10.1093/bjs/znac077 (added 18/07/2023)

•Consecutive women >16 who require a mastectomy for breast cancer or risk-reduction who:
•1. Elect to undergo immediate implant-based breast reconstruction
•2. Considered suitable for PPBR by their surgeon
•3. Understand and accept that PBRR is innovative and that outcome data are limited

•Absolute exclusion criteria:
•1. Thin/ insufficiently vascularised skin-flaps as assessed by the operating surgeon
•2. Revision /delayed breast reconstruction
•Additional relative exclusion criteria applied in line with the ABS/BAPRAS guidelines for mesh-assisted breast reconstruction for surgeons in the learning phase or early practice of prepectoral breast reconstruction:
•1. Smokers or ex-smokers <6 weeks
•2. Previous radiotherapy to the ipsilateral breast/chest wall
•3. BMI >30 (except for dermal sling procedures)
•4. Implant size >600cc
•5. Anticipated post-mastectomy radiotherapy
•6. Poorly controlled diabetes

发起方

niversity of Bristol