Project description:IntroductionThe emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions.Methods and analysisInternational, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm).Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles.Trial registration numberNCT04293146.

Project description:BackgroundAlthough video-assisted breast surgery is gaining popularity, endoscopic reconstruction after mastectomy is still facing lots of problems, bring about that endoscopic method has not yet become a standard procedure for breast cancer reconstruction. Here, we introduce a novel surgical technique of video-assisted transaxillary nipple-sparing mastectomy and immediate implant-based breast reconstruction and describe the detailed surgical procedure using this technique.MethodsDetailed steps of surgical procedure, the patient characteristics and the mean operative time of this new technique were described in this article. All patients were asked to score their satisfaction with their reconstructed breasts preoperatively, 1 month, 3 months, 6 months and 12 months postoperatively using the BREAST-Q.ResultsAt first, we used our "conventional method" and performed on 10 patients from April 2017 to June 2020; the operative time was 324.80 ± 66.39 minutes. After improving several procedures of the technique, the "optimized method" was performed on 14 cases from July 2020 to November 2020; the operative time decreased to 193.71 ± 28.75 minutes with shortest was 133 minutes; the optimized method was novel and easy to learn and be generalized. Most of the patients were satisfied with the reconstruction results. There was no significant difference between preoperative scores and scores at 3 months, 6 months and 12 months (p = 0.364). Since there is no wound on the breast dome, no obvious postoperative complications were observed except for one patient presented with infection.ConclusionsThis new technique has allowed surgeons to achieve excellent and reproducible outcomes in a single-stage procedure and represents an excellent technique for patients who wish to have a scarless and aesthetically pleasing appearance after mastectomy for breast cancer. This article also highlights the mean operative time (193.71 ± 28.75 minutes) that has been made possible with this new technique.Level of evidence vThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

Project description:PurposeNipple areola complex-sparing surgeries, such as nipple-sparing mastectomy (NSM), are increasingly used for women with early-stage breast cancer. In the postoperative setting, 2 major indications for postoperative radiation (PORT) with/without regional nodal irradiation (RNI) are: positive margins (margin+) and pathologically involved lymph nodes (pN+). The frequency of these adverse pathologic features and the rate of PORT utilization following NSM for these 2 indications are unknown. We determined the frequency of margin+ and pN+ following NSM compared with nipple-sparing lumpectomy/breast-conserving surgery [BCS] and identified trends in appropriate PORT administration for these standard indications in the NSM setting.Methods and materialsUsing the National Cancer Database (NCDB), women diagnosed with cT1 to cT3,N0M0 invasive carcinoma between 2004 and 2017 who underwent NSM were compared with those who underwent BCS (with nipple preservation). The frequencies of margin+ and pN+ by surgical subtype and use of PORT with/without RNI were assessed by cohort to determine if the type of surgery was associated with radiation delivery. Overall survival between the 2 cohorts was also compared. We performed univariable/multivariable logistic and Cox regression with ORs to control for confounders.ResultsOf 624,075 women included, 611,907 underwent BCS, and 12,168 underwent NSM. The surgical margin+ rate was significantly higher for NSM at 4.5% (n = 544) than for BCS at 3.7% (n = 22,449) (P < .001) and remained significant on multivariable analysis (MVA; OR, 1.13; CI, 1.03-1.25; P = .012). Use of PORT for margins+ was significantly lower by MVA after NSM (OR, 0.07; CI, 0.06-0.09; P < .001). Similarly, pN+ rate was significantly higher for NSM at 22.5% (n = 2740) versus BCS at 13.5% (n = 82,288) (P < .001), retaining significance on MVA (OR, 1.12; CI, 1.06-1.19; P < .001). For pN+ undergoing NSM, PORT with RNI was delivered significantly less often on MVA (OR, 0.73; CI, 0.67-0.81; P < .001). Neither high-risk subgroup had differences in overall survival on MVA.ConclusionsNSM is associated with a higher rate of margin+ and pN+ compared with BCS. Radiation is underused after NSM for these standard indications. Our results highlight the need to further refine patient selection for NSM and the importance of communicating the higher potential for adverse pathologic features (and thus, the potential need for radiation) to patients undergoing NSM.

Project description:BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

Project description:BackgroundOur center proposes a new technique that effectively provides space to broaden the surgical field of view and overcomes the limitations of endoscopy-assisted nipple-sparing mastectomy (E-NSM) by changing the dissection sequence and combining it with air inflation. The purpose of this study was to compare the clinical outcomes of the new technique designated "reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with subpectoral breast reconstruction (SBR)" and the conventional E-NSM (C-E-NSM) with SBR.MethodAll patients undergoing E-NSM with SBR at our breast center between April 2017 and December 2022 were included in this study. The cohort was divided into the C-E-NSM group and the R-E-NSM group. The operation time, anesthesia time, medical cost, complications, cosmetic outcomes, and oncological safety were compared.ResultsTwenty-six and seventy-nine consecutive patients were included in the C-E-NSM and R-E-NSM groups, with average ages of 36.9 ± 7.0 years and 39.7 ± 8.4 years (P=0.128). Patients in the R-E-NSM group had significantly shorter operation time (204.6 ± 59.2 vs. 318.9 ± 75.5 minutes, p<0.001) and anesthesia time (279.4 ± 83.9 vs. 408.9 ± 87.4 minutes, p<0.001) and decreased medical costs [5063.4 (4439.6-6532.3) vs. 6404.2 (5152.5-7981.5), USD, p=0.001] and increase SCAR-Q scores (77.2 ± 17.1 vs. 68.8 ± 8.7, P=0.002) compared to the C-E-NSM group. Although trends increased in both the excellent rate of Ueda scores (53.8% vs. 42.3%, P = 0.144), excellent rate of Harris scores (44.0% vs. 63.1%, P=0.102), and decreased surgical complications (7.6% vs. 19.2%, P = 0.135) were observed in the R-E-NSM group, the differences were not significant. There were no significant differences in oncological outcomes between the two groups.ConclusionR-E-NSM improves cosmetic outcomes and efficiency of C-E-NSM, reduces medical costs, and has a trend of lower surgical complications while maintaining the safety of oncology. It is a safe and feasible option for oncological procedures that deserves to be promoted and widely adopted in practice.

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Breast cancer patients’ postoperative outcomes in nipple-sparing mastectomy and reconstruction with subpectoral implant placement: a single center experience

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