scholarly journals Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e050173
Author(s):  
Ko Un Park ◽  
Sandy Lee ◽  
Angela Sarna ◽  
Matthew Chetta ◽  
Steven Schulz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Descriptive Analysis ◽  
Robot Assisted ◽  
En Bloc ◽  
Prospective Pilot Study ◽  
Link Type ◽  
Areolar Complex ◽  
Reference Number ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing

IntroductionNipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA.Methods and analysisThis is a single-arm prospective pilot study to determine the safety, efficacy and potential risks of RNSM. Up to 12 RNSM will be performed to assess the safety and feasibility of the procedure. Routine follow-up visits and study assessments will occur at 14 days, 30 days, 6 weeks, 6 months and 12 months. The primary outcome is to assess the feasibility of removing the breast gland en bloc using the RNSM technique. To assess safety, postoperative complication information will be collected. Secondary outcomes include defining benefits and challenges of RNSM for both surgeons and patients using surveys, as well as defining the breast and nipple-areolar complex sensation recovery following RNSM. Mainly, descriptive analysis will be used to report the findings.Ethics and disseminationThe RNSM protocol was reviewed and approved by the US Food and Drug Administration using the Investigational Device Exemption mechanism (reference number G200096). In addition, the protocol was registered with ClinicalTrials.gov (NCT04537312) and approved by The Ohio State University Institutional Review Board, reference number 2020C0094 (18 August 2020). The results of this study will be distributed through peer-reviewed journals and presented at surgical conferences.Trial registration numberNCT04537312.

scholarly journals Robot-assisted Nipple-sparing Mastectomy with Immediate Breast Reconstruction: An Initial Experience

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Hyung Seok Park ◽  
Jeea Lee ◽  
Dong Won Lee ◽  
Seung Yong Song ◽  
Dae Hyun Lew ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Breast Reconstruction ◽  
Learning Curve ◽  
Operation Time ◽  
Immediate Breast Reconstruction ◽  
Robot Assisted ◽  
Open Conversion ◽  
Areolar Complex ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing

Abstract Seeking smaller and indistinct incisions, physicians have attempted endoscopic breast surgery in breast cancer patients. Unfortunately, there are some limitations in the range of movement and visualization of the operation field. Potentially addressing these limitations, we investigated the outcomes of gas and gasless robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR). Ten patients underwent 12 RANSM with IBR between November 2016 and April 2018. Patients with tumors measuring >5 cm in diameter, tumor invasion of the skin or nipple-areolar complex, proven metastatic lymph nodes, or planned radiotherapy were excluded. Age, breast weight, diagnosis, tumor size, hormone receptor status, and operation time were retrospectively collected. Postoperative outcomes including postoperative complications and final margin status of resected were analyzed. The median total operation time and console time were 351 min (267–480 min) and 51 min (18–143 min), respectively. The learning curve presented as a cumulative sum graph showed that the console time decreased and then stabilized at the eighth case. There was no open conversion or major postoperative complication. One patient had self-resolved partial nipple ischemia, and two patients experienced partial skin ischemia. We deemed that RANSM with IBR is safe and feasible for early breast cancer, benign disease of the breast, and BRCA 1/2 mutation carriers. RANSM is an advanced surgical method with a short learning curve.

The Safety of Operating on Breasts With a History of Prior Reduction Mammoplasty: Dynamic Magnetic Resonance Imaging Analysis of Angiogenesis

2021 ◽  
Author(s):  
Joseph Kyu-hyung Park ◽  
Seokwon Park ◽  
Chan Yeong Heo ◽  
Jae Hoon Jeong ◽  
Bola Yun ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
Three Dimensional ◽  
Venous Drainage ◽  
Reduction Mammoplasty ◽  
Magnetic Resonance Images ◽  
Areolar Complex ◽  
Internal Mammary ◽  
Initial Procedure ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing

Abstract Background Vascularity of the nipple-areolar complex (NAC) is altered after reduction mammoplasty, which increases complications risks after repeat reduction or nipple-sparing mastectomy. Objectives To evaluate angiogenesis of the NAC via serial analysis of breast magnetic resonance images (MRIs). Methods Breast MRIs after reduction mammoplasty were analyzed for 35 patients (39 breasts) using three-dimensional reconstructions of maximal intensity projection images. All veins terminating at the NAC were classified as internal mammary, anterior intercostal, or lateral thoracic in origin. The vein with the largest diameter was considered the dominant vein. Images were classified based on the time since reduction: <6 months, 6-12 months, 12-24 months, >2 years. Results The average number of veins increased over time: 1.17 (<6 months), 1.56 (6–12 months), 1.64 (12–24 months), 1.73 (>2 years). Within 6 months, the pedicle was the only vein. Veins from other sources began to appear at 6–12 months. In most patients, at least two veins were available after 1 year. After 1 year, the internal mammary vein was the most common dominant vein regardless of the pedicle used. Conclusions In the initial 6 months after reduction mammoplasty, the pedicle is the only source of venous drainage; however, additional sources are available after 1 year. The internal thoracic vein was the dominant in most patients. Thus, repeat reduction mammoplasty or nipple-sparing mastectomy should be performed ≥1 year following the initial procedure. After 1 year, the superior or superomedial pedicle may represent the safest option when the previous pedicle is unknown.

scholarly journals Clinical Perspectives on Robot-assisted Nipple-sparing Mastectomy

2021 ◽  
Vol 2 (2) ◽  
pp. 23
Author(s):  
Joo Heung Kim ◽  
Jeea Lee ◽  
Jee Ye Kim ◽  
Haemin Lee ◽  
Hyung Seok Park
Keyword(s):  
Robot Assisted ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing

scholarly journals Clinical outcomes of patients after nipple-sparing mastectomy and reconstruction based on the expander/implant technique

Surgery Today ◽  
2020 ◽  
Author(s):  
Uhi Toh ◽  
Miki Takenaka ◽  
Nobutaka Iwakuma ◽  
Yoshito Akagi
Keyword(s):  
Breast Cancer ◽  
Breast Reconstruction ◽  
Gene Mutations ◽  
Cost Effective ◽  
Standard Of Care ◽  
Areolar Complex ◽  
Cost Effective Method ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing ◽  
Breast Reconstructive Surgery

AbstractAdvances in multi-modality treatments incorporating systemic chemotherapy, endocrine therapy, and radiotherapy for the management of breast cancer have resulted in a surgical-management paradigm change toward less-aggressive surgery that combines the use of breast-conserving or -reconstruction therapy as a new standard of care with a higher emphasis on cosmesis. The implementation of skin-sparing and nipple-sparing mastectomies (SSM, NSM) has been shown to be oncologically safe, and breast reconstructive surgery is being performed increasingly for patients with breast cancer. NSM and breast reconstruction can also be performed as prophylactic or risk-reduction surgery for women with BRCA gene mutations. Compared with conventional breast construction followed by total mastectomy (TM), NSM preserving the nipple–areolar complex (NAC) with breast reconstruction provides psychosocial and aesthetic benefits, thereby improving patients’ cosmetic appearance and body image. Implant-based breast reconstruction (IBBR) has been used worldwide following mastectomy as a safe and cost-effective method of breast reconstruction. We review the clinical evidence about immediate (one-stage) and delayed (two-stage) IBBR after NSM. Our results suggest that the postoperative complication rate may be higher after NSM followed by IBBR than after TM or SSM followed by IBBR.

Nipple-sparing mastectomy: Evaluation of oncologic safety and aesthetic outcomes in 94 patients.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 97-97
Author(s):  
E. C. Millen ◽  
R. R. Pinto ◽  
L. Menezes ◽  
F. C. O. Almeida ◽  
G. Novita ◽  
...  
Keyword(s):  
Breast Conservation ◽  
Tissue Expander ◽  
Radical Mastectomy ◽  
Breast Conservation Therapy ◽  
Axillary Node ◽  
Tertiary Referral Hospital ◽  
Immediate Reconstruction ◽  
Areolar Complex ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing

97 Background: The surgical treatment of breast cancer has evolved from radical mastectomy to breast conservation therapy. Today we have another therapeutic dilemma: how to manage the nipple-areolar complex (NAC) in mastectomy offering patients better aesthetic results with oncologic safety. Methods: We analyzed data on 125 consecutive nipple- or skin-sparing mastectomies (SSM) with immediate reconstruction with tissue expander, prosthesis or autologous tissue performed in 94 patients from 2003 to 2010 in a tertiary referral hospital. Nipple-sparing mastectomy (NSM) was performed for treatment disease (n= 94) and prophylaxis of contralateral breast or symmetrization in selected cases (n= 31). Results: Mean patients age was 46.8 years (range 27 to 69 years) and mean follow-up time was 27.2 months (range 2 weeks to 81 months). Twelve patients were stage 0, 41 stage I, 35 stage II A and B and 7 stage III. There were 125 nipple- or areola-sparing mastectomies (31 bilateral and 94 unilateral), including 112 NSM and 13 SSM. On pathologic review, 12 breasts had carcinoma in situ, 83 invasive carcinoma, and 31 breasts were cancer free. Thirteen nipples (13.8%) were compromised by tumor on subareolar biopsy and were removed. The location and type of incision was variable according to the tumor site and previous patient scar. Periareolar incision with prolongation along the inferior pole of breast was the preferred method. Patients with positive axillary node (27.5%) received adjuvant radiotherapy. There was no nipple necrosis. One patient presented local relapse in the skin-sparing group within 24 months. Conclusions: These data demonstrate that NSM is oncologically safe and can be performed with all types of breast reconstruction.

scholarly journals Comparison between Gasless and Gas-Inflated Robot-Assisted Nipple-Sparing Mastectomy

2021 ◽  
Vol 24 ◽  
Author(s):  
Haemin Lee ◽  
Jeea Lee ◽  
Kwanbum Lee ◽  
Jee Ye Kim ◽  
Hyung Seok Park
Keyword(s):  
Robot Assisted ◽  
Nipple Sparing Mastectomy ◽  
Nipple Sparing
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