Breast reconstruction Surgery
Conditions
Interventions
It is anticipated that patients entering the study will be followed up for 18 months.
Screening (using SEAR method)
Screening data will not include any patient identifiable information:
1. All patie
patient reported complications
18-month data
1. BREAST-Q completed (Reconstruction-pre-operative version)
Added 23/04/2020:
The intervention is prepectoral implant-based breast reconstruction perfor
Sponsors
University of Bristol
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 30 (except for dermal sling procedures) 4. Implant size >600cc 5. Anticipated post-mastectomy radiotherapy 6. Poorly controlled diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 08/04/2020: Implant loss rate at 3 months defined as: any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery Previous primary outcome measure: Implant loss rate at 3 months will be determined by clinical review carried out by participating surgeons at participating clinical sites. Implant loss is defined as: "any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery." | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/04/2020: 1. Other key safety measures including infection, return to theatre and reoperation, measured by clinical review at 3 months 2. Post-operative pain scores measured by VAS at 24 hours, 48 hours, 1 week and 3 months 3. Patient satisfaction with the outcome of their reconstruction assessed using the ‘satisfaction with breasts’ domain of the BREAST-Q at 18 months 4. Other patient-reported outcomes included in the breast reconstruction core outcome set including physical function, emotional well being and animation assessed using the BREAST-Q at 18 months 5. The feasibility of using mixed methods to promote shared learning and determine if the procedure is sufficiently stable for evaluation in the context of an RCT 6. The proportion of surgeons reporting modifications/complications; of these 7. The proportion of CRFs including details of modifications or learning arising from complications; of these 8. The proportion of surgeons agreeing to be interviewed; and of these 9. The proportion of interviews performed Previous secondary outcome measures: 1. Safety will be determined by comparing key safety outcomes for pre-pectoral breast reconstruction including infection; return to theatre and readmission at 3 months with published national audit data. All 3 measures will be determined by clinical teams and reported to the central study team as they occur. Definitions of all 3 measures are: 1.1. Infection- A hot, red swollen breast associated with one of the following; a temperature, pus at the wound site, a raised white cell count and/or; a positive wound swab within the first 3 months following surgery. This will be further classified as: 1.1.1. Minor – requiring oral antibiotics only; 1.1.2. Major 1 – requiring admission for IV antibiotics and/or debridement; 1.1.3. Major 2 – requiring surgical drainage/debridement 1.2. Readmission to hospital– any re-admission to hospital in the 3 months following surgery directly r | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactShelley Potter
Outcome results
None listed