Free Flaps in Patients with Advanced Arteriosclerosis of the Tibial Vessels: Mini Vein Graft to the Peroneal Artery.

Lower extremity reconstruction with free flaps in patients with only peroneal artery runoff remains a challenge. Here, we present a novel technique for reconstruction of medial defects in the distal leg using a medial approach to the peroneal artery and a short interposition vein graft anastomosed end to side to the peroneal artery. A retrospective, single-center study was performed including all patients who underwent lower extremity reconstruction with free flaps anastomosed to the peroneal artery using a mini vein graft from November 2020 to March 2022. The primary outcome measure was limb salvage. Secondary endpoints were flap survival and postoperative complications. Seven patients received lower extremity free flap reconstruction with a mini vein graft to the peroneal artery. Flap loss rate was 0%. Limb salvage was achieved in five patients (71%). At 6-month follow-up, all patients were ambulatory. One patient died 1 month after surgery due to heart failure. Mini vein graft to the peroneal artery allows reliable and safe free flap reconstruction of distal leg defects in patients with only peroneal artery runoff.

Improving quality of life after breast cancer: a comparison of two microsurgical treatment options for breast cancer-related lymphedema (BCRL).

PURPOSE: Vascularized lymph node transfer (VLNT) entails the autologous relocation of lymph nodes to a lymphedematous region of the body, whereas lymphaticovenous anastomosis (LVA) creates a direct bypass between the lymphatic and venous system. Both techniques are meant to lastingly bolster the local lymphatic drainage capacity. This study compared safety and effectiveness of VLNT and LVA in patients with chronic breast cancer related lymphedema (BCRL). METHODS: A retrospective cohort study was conducted using data from our encrypted database composed of patients with chronic BCRL who were treated with either VLNT or LVA and had a minimum follow-up of two years. Patient-specific variables analyzed included pre- and postoperative arm circumferences, lymphedema stages and postoperative complications. RESULTS: A total of 105 patients met the inclusion criteria, of which 96 patients demonstrated a complete follow-up period of two years. The VLNT group displayed larger preoperative circumferential measurements, evident in both in the isolated examination of the affected arm, as well as when adjusted for the contralateral unaffected arm. Significant reduction in arm volume was achieved by both groups. However, VLNT demonstrated superior relative reduction rates than LVA, neutralizing any significant arm size disparities after 24 months. Surgery duration was slightly longer for VLNT than LVA. Postoperative complications, predominantly minor, were exclusively observed in the VLNT group. CONCLUSIONS: Both VLNT and LVA offer significant improvement for patients suffering from chronic BCRL. VLNT shows an even greater potential for improvement in more severe cases of BCRL, but involves a higher risk for (mostly minor) complications.

Cylindroma of the breast with CYLD gene mutation: a case report and review of the literature.

BACKGROUND: Cylindroma of the breast is a rare benign neoplasm. Since its first description in 2001, 20 cases have been reported in the literature. METHODS AND RESULTS: We report another case of this rare tumor in a 60-year-old woman with demonstration of the underlying molecular alteration. Histologically, the tumor showed the typical "jigsaw" pattern of a dual population of cells with a triple-negative phenotype. The pathognomonic mutation of the CYLD gene mutation was detected by whole exome sequencing. Cylindromas show morphological overlap with the solid-basaloid variant of adenoid cystic carcinoma, which renders this differential diagnosis difficult. However, distinction of these two lesions is of outmost importance, since cylindromas, in contrast to solid-basaloid variant of adenoid cystic carcinoma, behave in an entirely benign fashion. CONCLUSIONS: Careful evaluation of morphological features such as mitotic figures and cellular atypia is crucial in the diagnostic work-up of triple-negative breast lesions. It is important to keep cylindroma in mind as a pitfall and possible differential diagnosis for the solid-basaloid variant of adenoid cystic carcinoma. Molecular detection of CYLD gene mutation is helpful in cases with ambiguous histology. With this case report, we aim to contribute to a better understanding of mammary cylindroma and facilitate the diagnosis of this rare entity.

Uncertainties and controversies in axillary management of patients with breast cancer.

The aims of this Oncoplastic Breast Consortium and European Breast Cancer Research Association of Surgical Trialists initiative were to identify uncertainties and controversies in axillary management of early breast cancer and to recommend appropriate strategies to address them. By use of Delphi methods, 15 questions were prioritized by more than 250 breast surgeons, patient advocates and radiation oncologists from 60 countries. Subsequently, a global virtual consensus panel considered available data, ongoing studies and resource utilization. It agreed that research should no longer be prioritized for standardization of axillary imaging, de-escalation of axillary surgery in node-positive cancer and risk evaluation of modern surgery and radiotherapy. Instead, expert consensus recommendations for clinical practice should be based on current evidence and updated once results from ongoing studies become available. Research on de-escalation of radiotherapy and identification of the most relevant endpoints in axillary management should encompass a meta-analysis to identify knowledge gaps, followed by a Delphi process to prioritize and a consensus conference to refine recommendations for specific trial designs. Finally, treatment of residual nodal disease after surgery was recommended to be assessed in a prospective register.

Good Manufacturing Practice-compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product-a comparability study.

The development of medicinal products often continues throughout the different phases of a clinical study and may require challenging changes in raw and starting materials at later stages. Comparability between the product properties pre- and post-change thus needs to be ensured. Here, we describe and validate the regulatory compliant change of a raw material using the example of a nasal chondrocyte tissue-engineered cartilage (N-TEC) product, initially developed for treatment of confined knee cartilage lesions. Scaling up the size of N-TEC as required for the treatment of larger osteoarthritis defects required the substitution of autologous serum with a clinical-grade human platelet lysate (hPL) to achieve greater cell numbers necessary for the manufacturing of larger size grafts. A risk-based approach was performed to fulfill regulatory requirements and demonstrate comparability of the products manufactured with the standard process (autologous serum) already applied in clinical indications and the modified process (hPL). Critical attributes with regard to quality, purity, efficacy, safety and stability of the product as well as associated test methods and acceptance criteria were defined. Results showed that hPL added during the expansion phase of nasal chondrocytes enhances proliferation rate, population doublings and cell numbers at passage 2 without promoting the overgrowth of potentially contaminant perichondrial cells. N-TEC generated with the modified versus standard process contained similar content of DNA and cartilaginous matrix proteins with even greater expression levels of chondrogenic genes. The increased risk for tumorigenicity potentially associated with the use of hPL was assessed through karyotyping of chondrocytes at passage 4, revealing no chromosomal changes. Moreover, the shelf-life of N-TEC established for the standard process could be confirmed with the modified process. In conclusion, we demonstrated the introduction of hPL in the manufacturing process of a tissue engineered product, already used in a late-stage clinical trial. Based on this study, the national competent authorities in Switzerland and Germany accepted the modified process which is now applied for ongoing clinical tests of N-TEC. The described activities can thus be taken as a paradigm for successful and regulatory compliant demonstration of comparability in advanced therapy medicinal products manufacturing.

Reducing Postoperative Swelling, Edema, and Ecchymosis after Open Rhinoplasty Using Intranasal Drainage.

Reducing postoperative strain on the patient after rhinoplasty is an important goal for the surgeon. Many strategies are described to reach that goal. One strategy is to remove blood from under the dissected soft tissue envelope by drains, before it can infiltrate the different layers causing ecchymosis, edema, and swelling. In our setting with wide degloving and using drains, we could show a significant reduction in ecchymosis on day 2 and 14 after surgery (p = 0.006 and p = 0.017). We also observed a significant effect for edema and general swelling on day 2 (p = 0.027 and p = 0.004), but this effect did not reach significance for these two parameters on day 14. And although the long-term effect needs to be assessed in the future, we found that using drains in open rhinoplasty with wide degloving is an easily applicable, cheap, and reproducible approach to reduce postoperative ecchymosis, edema, and swelling.

Combining reconstructive and ablative surgical treatment of chronic breast cancer-related lymphedema (BCRL): safe and effective.

PURPOSE: We investigated whether a one-stage combination of vascularized lymph node transfer (VLNT) with water jet-assisted liposuction (WAL) can be safely performed and results in improved patient outcomes such as a greater reduction in arm volume when treating chronic breast cancer-related lymphedema (BCRL). METHODS: In this retrospective cohort study, we included all patients from our encrypted lymphedema database treated for chronic BCRL with VLNT or VLNT + WAL who had a minimum follow-up of two years. We analyzed patient-specific variables including arm circumferences as well as patient-reported outcomes before and after surgery as well as surgery time, surgery-related complications and patient satisfaction. RESULTS: Only the mean preoperative differences of the circumferences between the lymphedematous and the unaffected arm in individual patients showed a statistically significant difference between treatment groups (p < 0.05). Indeed, patients treated with VLNT + WAL had consistently larger differences in individual sets of arms and therefore more pronounced chronic BCRL. The mean surgery time was significantly longer in the VLNT + WAL group (p < 0.05). Complications were seldom and similar in both groups. Using a numeric rating scale, the level of patient satisfaction following treatment did not differ significantly between groups (p = 0.323). CONCLUSIONS: Our findings suggest that a one-stage combination of VLNT with WAL does not result in more complications even though it also entails a longer surgery time. This is acceptable as secondary interventions resulting in overall longer surgery times and higher costs can be avoided. A one-stage combination might be especially favourable for patients suffering from more severe chronic BCRL.

Impact of Adjuvant Radiotherapy on Free Flap Volume in Autologous Breast Reconstruction: A Scoping Review.

In autologous breast reconstruction, a sufficient flap volume is fundamental to restore breast shape and ensure an aesthetic outcome. After mastectomy, postoperative irradiation is regularly indicated in the oncological treatment algorithm. When administering radiation therapy after autologous reconstruction, the tissue transferred is inherently irradiated. Although there is evidence that points to a reduction in flap volume after adjuvant radiotherapy, the data have been contradicting and inconclusive. To address this anecdotal evidence, we performed a scoping review of the current literature that addresses the effect of radiotherapy on breast flap volume. Six two-armed studies, comprising a total of 462 patients, reported on the effect of adjuvant radiotherapy on free flap volume changes. Of those, two studies found a significant negative impact of radiotherapy on free flap volume, while the other four studies did not. Reported flap volume changes ranged from no change to a reduction of 26.2%, measured up to two years postoperatively. The selected studies contain varying patient numbers, follow-up timepoints, types of flaps, and measuring methods, contributing to a relatively high heterogeneity. While we present some evidence suggesting a significant impact of adjuvant radiotherapy on breast flap volume, future studies are needed to further investigate this potential correlation.

Vascularized and Non-vascularized Fibula Grafts in Tumour Reconstruction: Single Centre Experience With Mid to Long-term Results.

BACKGROUND/AIM: Vascularized (VFG) and non-vascularized fibula grafts (NVFG) are used in reconstruction of bone defects after tumour resection. This study compared both autografts and their results, risk factors, and complications. PATIENTS AND METHODS: Tumour resection and reconstruction by using VFG (n=17) and NVFG (n=36) were performed in 53 patients at our institute (range=3-65 years of age, mean: 21.2 ± 13.2 years) of which 24 were female. Malignant tumours were diagnosed in 26 patients (VFG=16 patients-94%). The mean follow-up was 14.9 years (range=1.5-43 years). Factors like consolidation, functional and oncologic outcomes, and complications were analysed. RESULTS: In total, 75 struts of fibula were obtained. The mean length of the fibula was 16.3 cm (16 in NVFG and 16.5 in VFG). The mean union time was 13 months (6 to 25 months) overall. Hypertrophy was found in 65 of 75 grafts (86.7%) and consolidation was found in 69 (92%). Hypertrophy was similar in VFG (85.3%) and NVFG (87.1%). Complication rate in VFG was 41% and in NVFG 25%. Fractures were found in 7 (13%), infections in 4 (7.5%), and non-union in 5 (9.4%) patients. Chemotherapy was the only negative prognostic factor for union time (p=0.021). CONCLUSION: Both VFG and NVFG are used with successful results in the reconstruction of segmental bone tumour defects. With lower complication rates, NVFG showed comparable results to VFG but is limited in indication by size for greater defects, and malignant tumours. Chemotherapy is an adverse factor leading to prolonged union time in both techniques.

The impact of delayed wound healing on patient-reported outcomes after breast cancer surgery.

PURPOSE: Postoperative complications after breast cancer surgery may be associated with decreased quality of life. It remains unclear whether oncoplastic breast-conserving surgery or mastectomy with reconstruction lead to more postoperative complications than conventional breast surgery (CBS). As delayed wound healing (DWH) is one of the most frequent minor complications, we sought to investigate the significance of DWH for patient-reported outcomes after oncoplastic, reconstructive, and CBS. METHODS: Our study is a retrospective cohort study of consecutive patients with stage I-II breast cancer who underwent oncoplastic or CBS performed by three breast surgeons at a single tertiary referral hospital from June 2011 until May 2019. Patient-reported outcomes were evaluated postoperatively using the BREAST-Q questionnaire. Comparisons were made between patients with and without DWH. RESULTS: A total of 229 patients who met the inclusion criteria and 28 (12%) of them developed DWH, 27/158 (17%) in the oncoplastic breast-conserving surgery and reconstruction group and 1/71 (1%) in the CBS group. The mean time from surgery to BREAST-Q assessment was comparable in both groups (29 months in the DWH vs. 33 months in the normal wound healing group). No statistically significant difference for any BREAST-Q scale was detected between patients with and without DWH. This includes physical (p = 0.183), psychosocial (p = 0.489), sexual well-being (p = 0.895), and satisfaction with breasts (p = 0.068). CONCLUSION: Our study confirms that oncoplastic breast-conserving surgery and mastectomy with reconstruction lead to significantly more DWH than CBS. However, neither quality of life nor patient-reported outcomes following state-of-the-art reconstructive or oncoplastic breast-conserving surgery at a specialized center seem to be compromised.

In Vitro and Ectopic In Vivo Studies toward the Utilization of Rapidly Isolated Human Nasal Chondrocytes for Single-Stage Arthroscopic Cartilage Regeneration Therapy.

Nasal chondrocytes (NCs) have a higher and more reproducible chondrogenic capacity than articular chondrocytes, and the engineered cartilage tissue they generate in vitro has been demonstrated to be safe in clinical applications. Here, we aimed at determining the feasibility for a single-stage application of NCs for cartilage regeneration under minimally invasive settings. In particular, we assessed whether NCs isolated using a short collagenase digestion protocol retain their potential to proliferate and chondro-differentiate within an injectable, swiftly cross-linked and matrix-metalloproteinase (MMP)-degradable polyethylene glycol (PEG) gel enriched with human platelet lysate (hPL). NC-hPL-PEG gels were additionally tested for their capacity to generate cartilage tissue in vivo and to integrate into cartilage/bone compartments of human osteochondral plugs upon ectopic subcutaneous implantation into nude mice. NCs isolated with a rapid protocol and embedded in PEG gels with hPL at low cell density were capable of efficiently proliferating and of generating tissue rich in glycosaminoglycans and collagen II. NC-hPL-PEG gels developed into hyaline-like cartilage tissues upon ectopic in vivo implantation and integrated with surrounding native cartilage and bone tissues. The delivery of NCs in PEG gels containing hPL is a feasible strategy for cartilage repair and now requires further validation in orthotopic in vivo models.

Brustrekonstruktion ­ der Einfluss des Verfahrens auf die Lebensqualität.

English Breast cancer and the surgical procedures associated with it have a major impact on the quality of life of affected patients. Research shows that the loss of the breast and the associated change in body image have a major impact on the female self-image for many women. This has a strong negative impact on the quality of life of those affected. With modern clinical outcome research including treatment results from the patient's perspective in the form of patient-reported outcome measures (PROMs), the satisfaction and quality of life of those affected can be measured, analysed and compared. This review examines the extent to which breast reconstruction improves the quality of life for many women and how the different reconstruction methods vary in their impact on quality of life and satisfaction. In addition, the review discusses the importance of standardised recording and analysis of PROMs in combination with objective clinical data and their integration into the treatment process, and it demonstrates implementation options. Such systematic recording of PROMs enables the creation of databases and registers, the evaluation of which provides information that can be used for scientific and clinical purposes. Based on these research results, prognostic models can be created and treatment results can be examined in comparative studies facilitating clinical decision-making and quality controls.

Comparison of patient-reported outcomes among different types of oncoplastic breast surgery procedures.

BACKGROUND: This study aims to compare patient-reported outcomes (PROs) after different types of oncoplastic surgery (OPS) procedures and correlate the results with previously published normative data from women with no prior history of breast cancer (BC) and breast surgery. METHODS: Cross-sectional study of patients with stage I-II BC undergoing a specific selection of OPS procedures from 04/2012 to 12/2018 by three breast surgeons at a single tertiary referral hospital in Switzerland. PROs were evaluated using the postoperative BREAST-Q questionnaire. RESULTS: One hundred twenty-seven patients met the inclusion criteria and were surveyed. All OPS techniques achieved comparably elevated scores in satisfaction with breasts, psychosocial, and sexual well-being. Compared to normative data of healthy women, all OPS groups postoperatively achieved significantly better satisfaction with breasts, psychosocial, and sexual well-being. CONCLUSION: This study shows high PROs across all types of OPS, which were superior to normative data from healthy women. Our findings confirm that OPS is associated with high quality of life and patient satisfaction.

Oncoplastic breast consortium recommendations for mastectomy and whole breast reconstruction in the setting of post-mastectomy radiation therapy.

AIM: Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. METHODS: A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. RESULTS: The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. CONCLUSIONS: The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR.

The double S technique to achieve aesthetic flat closure after conventional mastectomy.

BACKGROUND: Lateral excess tissue after mastectomy is a frequent problem, which should be included into preoperative planning. Women with lateral tissue abundance are frequently impaired cosmetically and functionally. We suggest a novel oncoplastic mastectomy technique to eliminate the above mentioned. METHODS: Surgical technique Two small horizontal lines are drawn, one line above and one line below the Nipple Areola Complex. These lines should represent the possible skin excision and allow tight skin closure. Consecutively, two ending points of the incision are planned, one close to the xyphoid area and the other one in the anterior axillary line. These points are then interconnected in an s-shaped manner to form a double s-shaped skin excision. RESULTS: The double S-shaped technique is an easy reproducible technique which not only allows good access to the lateral side of the mastectomy, but also and mainly the reduction of lateral fat and skin. CONCLUSION: The double S mastectomy allows for simultaneous removal of access in the axillary region, eliminating skin, and fat as needed and preventing the lateral dog ear.

Three-Dimensional Technology in Rhinoplasty.

Rhinoplasty is uniquely suited to capitalize on different aspects of three-dimensional (3D) modeling technology. Currently, 3D surface imaging of preoperative and postoperative nasal structure provides a platform for better surgical planning and patient counselling as well as objective postoperative measurements. Physical nasal models using 3D printing technology can improve rhinoplasty performance intraoperatively, postoperative outcomes, together with nasal prosthetic manufacture, by tailoring to specific patient anatomy. Advances in tissue engineering using 3D-printed biocompatible scaffolds have shown excellent nasal cartilage mimicry and hold promise for increasingly versatile directed tissue regeneration in rhinoplasty and nasal reconstructive surgery. As health care innovations are expected to become increasingly common in standard rhinoplasty practices in the future, we give an account of how 3D technologies can create new opportunities to optimize surgical planning and improve overall the patient experience.

Impact of Oncoplastic Breast Surgery on Rate of Complications, Time to Adjuvant Treatment, and Risk of Recurrence.

BACKGROUND: The aim of this study was to compare the risk of complications and recurrence between oncoplastic and conventional breast surgery. METHODS: This is a retrospective analysis of a consecutive series of 436 patients with stage I-III breast cancer who underwent surgery at the University Hospital of Basel between 2011 and 2018. RESULTS: The nipple/skin-sparing mastectomy (NSM/SSM) group showed significantly more delayed wound healing (32.7 vs. 5.8%, p < 0.001) and skin necrosis (13.9 vs. 1.9%, p = 0.020) compared to conventional mastectomy (CM), which corresponded to significantly higher odds of short-term complications (OR 2.34, 95% CI 1.02-5.35, p = 0.044). The incidence rate of long-term morbidity in oncoplastic breast-conserving surgery (OBCS) was significantly higher compared to conventional breast-conserving surgery (CBCS; 25.5 vs. 11.3 per 100 patient years [PY], p < 0.001), in particular concerning chronic pain (13.3 vs. 6.6, p = 0.011) and lymphedema (4.1 vs. 0.4, p = 0.003). Seroma as a long-term morbidity occurred more often in the CM group compared to the NSM/SSM group (5.8 vs. 0.5 per 100 PY, p = 0.004). Patients received adjuvant treatment earlier after CM compared to NSM/SSM (HR 1.83, 95% CI 1.05-3.19, p = 0.034). There were no significant differences in the incidence of positive margins nor in the odds of recurrence after OBCS versus CBCS and after NSM/SSM versus CM. CONCLUSIONS: Even though the present study confirmed expected differences in complications and morbidity, it suggested that oncoplastic surgery is oncologically safe. Patients undergoing NSM/SSM should be followed closely to allow early detection and treatment of frequently associated complications and ensure timely start of adjuvant therapy.

Vascularized Bone Graft Reconstruction Following Bone Tumor Resection at a Multidisciplinary Sarcoma Center: Outcome Analysis.

BACKGROUND/AIM: Limb-sparing procedures are frequently applied to improve patient outcomes. The use of vascularized bone grafts is associated with significant improvements in oncologic safety and functional satisfaction. This study highlights the clinical outcomes following tumor resection combined with vascularized bone graft reconstructions. PATIENTS AND METHODS: Twenty-five free vascularized bone grafts (17 fibulas, 5 iliac crests, 3 medial femoral condyles) were assessed with respect to consolidation and hypertrophy, functional and oncologic outcomes, and local complications. RESULTS: The rate of healing of fibular grafts after a median of 5 months was 86%. The rate of achieved unions of iliac crest grafts after a median of 5 months was 80%. In medial femoral condyle bone grafts, union occurred after a median of 4 months. Significant hypertrophy was observed in 13 patients. We identified six complications with highest rates in the fibula-group. Despite the high complications, functional results were highly satisfactory. CONCLUSION: Vascularized bone grafts represent a reconstructive approach, maintaining long-term functionality and cosmetic satisfaction without compromising tumor recurrence outcomes.

Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial.

INTRODUCTION: The 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 ANALYSIS: International, 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 DISSEMINATION: This 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 NUMBER: NCT04293146.