scholarly journals The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e033641
Author(s):  
Kate Louise Harvey ◽  
Nicola Mills ◽  
Paul White ◽  
Christopher Holcombe ◽  
Shelley Potter
Keyword(s):  
Cohort Study ◽  
Mixed Methods ◽  
Breast Reconstruction ◽  
Free Text ◽  
Short Term ◽  
Current Standard ◽  
Long Term Study ◽  
South Central ◽  
Free Text Response ◽  
Patient Reported

IntroductionImplant-based breast reconstruction is the most commonly performed reconstructive technique worldwide. Subpectoral reconstruction with mesh is the current standard of care but new prepectoral techniques have recently been introduced. Prepectoral breast reconstruction (PPBR) may improve outcomes for patients but robust evaluation is required. Randomised clinical trials (RCTs) are ideally needed but the short-term safety of PPBR is yet to be established; the technique and its indications are evolving and it has yet to be adopted by a sufficient number of surgeons for an RCT to be feasible.The Pre-BRA study aims to determine the feasibility of using mixed-methods within an IDEAL 2a/2b (IDEAL, Idea-Development-Exploration-Assessment-Long-term) study to explore the short-term safety of PPBR and determine when the technique is sufficiently stable for evaluation in a pragmatic RCT.Methods and analysisPre-BRA is an IDEAL stage 2a/2b prospective multicentre cohort study with embedded qualitative research.Consecutive patients electing to undergo immediate PPBR at participating centres will be invited to participate. Demographic, operative, oncology and complication data will be collected and patient-reported outcomes will be assessed at baseline, 3 and 18 months postoperatively. The primary safety endpoint will be implant loss at 3 months.Surgeons performing PPBR will be asked to complete questionnaires regarding their practice and report any modifications made to the procedure or learning arising from complications via free-text response fields on electronic case-report forms. Semistructured will explore surgeons’ experiences in detail to identify emerging best practice. This will be fed back to participating surgeons to promote shared learning.The Pre-BRA study will aim to recruit 341 patients from 30 to 40 UK centres over a 12-month period. Recruitment will commence Spring 2019.Ethics and disseminationThe study has full ethical approval from OXFORD-B South Central Committee Ref:19/SC/0129. Results will be presented at national and international meetings and published in peer-reviewed journals.Trial registration numberISRCTN11898000; Pre-results.

scholarly journals Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

2019 ◽  
Vol 20 (2) ◽  
pp. 254-266 ◽  
Author(s):  
Shelley Potter ◽  
Elizabeth J Conroy ◽  
Ramsey I Cutress ◽  
Paula R Williamson ◽  
Lisa Whisker ◽  
...  
Keyword(s):  
Cohort Study ◽  
Breast Reconstruction ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Short Term ◽  
Safety Outcomes ◽  
Immediate Implant

scholarly journals O77: DOES MESH IMPROVE PATIENT SATISFACTION AND HEALTH-RELATED QUALITY OF LIFE AFTER IMPLANT-BASED BREAST RECONSTRUCTION? A MULTICENTRE PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
E Sewart ◽  
N Turner ◽  
EJ Conroy ◽  
R Cutress ◽  
J Skillman ◽  
...  
Keyword(s):  
Cohort Study ◽  
Breast Reconstruction ◽  
Reference Group ◽  
Random Effect ◽  
Synthetic Mesh ◽  
Early Data ◽  
Supporting Evidence ◽  
Two Stage ◽  
Patient Reported ◽  
Dermal Sling

Abstract Introduction Biological and synthetic meshes may improve outcomes of immediate IBBR by facilitating single-stage direct-to-implant procedures. However, high-quality supporting evidence is limited, particularly regarding PROs. Method 2108 consecutive women undergoing IBBR at 81 centres were prospectively recruited between 2014-2016. Demographic, operative, oncological and 3-month complication data were collected. An 18-month questionnaire assessed PROs using the validated BREAST-Q and a five-point Likert scale rating of overall reconstructive outcome. The impacts of different IBBR techniques on PROs were explored using mixed-effects regression models adjusted for clinically-relevant confounders and including a random effect to account for clustering by centre. The reference group was two- stage submuscular reconstruction without mesh. Result 1470 participants consented to receive the questionnaire and 891 completed it. 67 patients underwent two-stage submuscular reconstruction; 764 patients received subpectoral reconstructions with biological mesh (n=495) synthetic mesh (n=95) or dermal sling (n=174). 14 patients underwent prepectoral reconstructions (introduced late in the study). Compared with two-stage reconstructions, no differences in PROs were seen in biological or synthetic mesh-assisted or dermal sling procedures (p>0.05). However, prepectoral IBBR patients reported better satisfaction with breasts (difference=6.63, 95% confidence interval[1.65–11.61], p=0.009). Outcomes were similar to those in the NMBRA 2008/9 cohort, which included submuscular procedures only. Conclusion This study does not suggest that mesh improves PROs of IBBR. It provides early data supporting improved satisfaction with breasts following prepectoral reconstructions. Future trials are needed to robustly evaluate prepectoral techniques. Abbrev IBBR: implant-based breast reconstruction, PRO: patient-reported outcome, NMBRA: National Mastectomy and Breast Reconstruction Audit Take-home message Although mesh-assisted techniques have become widely adopted, this large, prospective, multicentre cohort study does not suggest that mesh improves patient-reported outcomes of implant-based breast reconstruction compared with standard submuscular techniques. However, it provides early data to support improved satisfaction with breasts in the prepectoral setting, which now requires robust evaluation.

scholarly journals O58: THE IMPACT OF RADIOTHERAPY ON PATIENT-REPORTED OUTCOMES OF IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION: RESULTS OF A PROSPECTIVE MULTICENTRE COHORT STUDY

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
E Sewart ◽  
N Turner ◽  
EJ Conroy ◽  
R Cutress ◽  
J Skillman ◽  
...  
Keyword(s):  
Cohort Study ◽  
Breast Reconstruction ◽  
Patient Reported Outcomes ◽  
Random Effect ◽  
Well Being ◽  
Patient Reported Outcome ◽  
Complication Rates ◽  
Informed Decisions ◽  
Patient Reported ◽  
The Impact

Abstract Introduction Post-mastectomy radiotherapy (PMRT) is increasing given to improve breast cancer outcomes but can increase complication rates following implant-based breast reconstruction (IBBR). Little, however, is known about the impact of PMRT on patient-reported outcomes (PROs) of IBBR, especially in the context of mesh-assisted techniques. Method 2108 consecutive women undergoing IBBR at 81 UK centres were prospectively recruited between 2014 and 2016. Demographic, operative, oncological and 3-month complication data were collected, and patients who consented received post-operative questionnaires. An 18-month questionnaire assessed PROs using the validated BREAST-Q. The effect of IBBR on PROs was investigated using mixed-effects regression models adjusted for clinically relevant confounders and including a random effect to account for potential clustering by centre. Result 1693 iBRA participants underwent mastectomy for malignancy, of whom 1187 (70%) consented to receive the 18-month questionnaire and 732 (43%) completed it. Patients undergoing PMRT (n=214) reported significantly worse scores across 3 BREAST-Q domains: satisfaction with breasts (-6.27 points, p=0.008, 95% confidence interval (CI)[-10.91,-1.63]), satisfaction with outcome (-7.53 points, p=0.002, CI[-12.20,-2.85]) and physical well-being (-6.55 points, p<0.001, CI[-9.43,-3.67]). Overall satisfaction was worse in the PMRT group (OR 0.497, p=0.002, CI[0.32,0.77]). Use of biological mesh did not ameliorate the impact of PMRT on patient satisfaction (interaction term p-values [0.173 - 0.826]). Conclusion: PMRT adversely affects PROs of IBBR. This should be discussed with patients considering IBBR, especially if PMRT is anticipated or indications are borderline, to enable informed decisions regarding oncological and reconstructive options. Abbrev PMRT: post-mastectomy radiotherapy, PRO: patient-reported outcome Take-home message This multicentre, prospective cohort study of 732 patients undergoing implant-based breast reconstruction demonstrates worse 18-month patient-reported outcomes in women who received post-mastectomy radiotherapy than those who did not. These data should be discussed with patients to help them make informed decisions about reconstructive surgery.

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