Implant-based breast reconstruction following mastectomy for breast cancer or risk reduction Surgery
Conditions
Interventions
Women who require a mastectomy for either breast cancer or risk reduction and elect to have an IBRR will be recruited and randomised 1:1 for either a subpectoral or pre-pectoral implant reconstruction
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Require a mastectomy for breast cancer or risk-reduction 3. Elect to undergo immediate IBBR 4. Considered eligible for either pre or subpectoral reconstruction by the surgical team
Exclusion criteria
Exclusion criteria: 1. Had a delayed reconstruction 2. Has had revision breast reconstruction surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessed throughout the duration of the trial using screening logs: 1. Recruitment into trial (number of sites recruiting; proportion of eligible women approached that are randomised, women recruited per site per month) 2. Adherence to trial allocation by comparing number of women allocated to trial intervention vs. their actual reconstruction (i.e pre-pec or subpectoral IBBR) 3. Completion rates measured by overall data completeness (% missing data) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Satisfaction with breasts using the validated BREAST-Q questionnaire at 12 months 2. Surgical complications, in particular implant loss, infection, re-admission and reoperation measured using patient records at 3 and 12 months 3. Need for additional surgery to the reconstruction or the contralateral breast measured using patient records at 12 months 4. Pain scores assessed using a visual analogue scale (VAS) at 24 hours and 1 week 5. Objective cosmetic outcome at 12 months assessed using routinely collected patient photographs 6. EQ-5D-5L health-related quality of life score at 12 months 7. Wellbeing (ICECAP-A) score at 12 months 8. Patient-reported outcome domains included in the breast reconstruction core outcome set including physical well-being (chest); emotional well-being; and animation assessed using appropriate subscales of the BREAST-Q at 12 months 9. Cost-effectiveness of pre-pectoral and subpectoral IBBR assessed by micro-costing the two procedures. Data will be gathered from electronic notes/medical records as well as routine data | — |
Countries
England, United Kingdom
Contacts
Public ContactKirsty Roberts
Outcome results
None listed