The pre-pectoral breast reconstruction evaluation study

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."

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 related to the procedure (e.g. with infection requiring antibiotics).
1.3. Return to theatre – Return to the operating theatre at any time during the first 3 months following surgery to deal with any complication of the reconstruction. This will not include any secondary oncological procedures such as axillary clearance or planned procedures including exchange of expander for a fixed volume implant or lipo-modelling.
2. The feasibility of using mixed methods to promote shared learning and identify when the technique is sufficiently stable for evaluation in the context of an RCT will be determined by:
2.1. The number of surgeons reporting modifications to their patient selection criteria or technique, or a post-operative complication via individual patient case report forms (CRFs). Each time one of these events occur, surgeons will be contacted and invited to take part in qualitative interviews to explore these events in further detail. The number of surgeons reporting events via CRFs and agreeing to qualitative interviews will determine the feasibility of these novel methods.
3. The feasibility, design and conduct of a future RCT will be determined by exploring the numbers of patients potentially eligible for pre-pectoral reconstruction; the types and frequencies of products used and approaches to concomitant interventions. This will be measured by:
3.1. Before the study - A national practice survey of both clinical sites and individual surgeons to determine how widely pre-pectoral breast reconstruction (PPBR) is practiced and how widely the technique varies from the point of view of products used and approaches to concomitant interventions (e.g. use of surgical drains and antibiotics) at the start of the study.
3.2. During the study - detailed screening logs will be kept at each clinical site of how many cases are suitable for implant-based breast reconstruction (IBBR), and within this group how many of those would be technically suitable for PPBR? And of those suitable for PPBR, how many go on to have the technique and if they don't choose to, their reasons. This will inform the feasibility of potentially randomising between IBBR and PPBR in a future study.
3.3. At the close of the study - how many surgeons have taken part, what proportion have engaged with qualitative interviews. And how many surgeons report (via individual patient CRFs) that sequential operations they have performed have not been modified i.e. the procedure is stable, and can be evaluated in a randomised controlled trial.
4. The capacity to deliver a future RCT will be determined by the success of 1, 2 and 3