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Clinical Trial Summary

The purpose of the study: It provides the highest level of evidence ever studied on the use of robotic surgical systems during breast surgery for breast cancer treatment, and aims to reveal the clinical significance of successive breast reconstruction(immediate breast reconstruction, IBR) at the same time as robotic assisted papillary preservation mastectomyRobot-assisted nipple-sparing mastectomy, RNSM)


Clinical Trial Description

- Detail: This study is a multi-organ randomized clinical trial that evaluates oncological results of RNSM compared to conventional papillary preservation mastectomy (Conventional Nipple Sparing Mastectomy, CNSM). Retrospective studies on robot-endoscopic surgery have shown that beginners are technically feasible and reliable with a short learning curve. However, the absence of a well-organized randomized trial remains a major limitation in expanding robotic surgery in breast surgery worldwide, so in this study, we designed a prospective multi-organ randomized trial 'Robot-to-Open Nipple Preservation Mastectomy Clinical Trial' compared to CNSM for oncological results after RNSM and IBR. - Description: This study is a multi-organ randomized clinical trial that evaluates oncological results of RNSM compared to conventional papillary preservation mastectomy (Conventional Nipple Sparing Mastectomy, CNSM). Retrospective studies on robot-endoscopic surgery have shown that beginners are technically feasible and reliable with a short learning curve. However, the absence of a well-organized randomized trial remains a major limitation in expanding robotic surgery in breast surgery worldwide, so in this study, we designed a prospective multi-organ randomized trial 'Robot-to-Open Nipple Preservation Mastectomy Clinical Trial' compared to CNSM for oncological results after RNSM and IBR. - Data collection: Collections of clinical pathological factors include height, weight, breast volume/weight, age, germline likely pathogenic/pathogenic mutation, affected breast, bilateral surgery, breast ptosis, Tumor size, TNM stage, histological grade, histological type, estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor (HER), Ki67 levels, papillary invasion status, adjuvant/neoplastic treatment status, and postoperative complications by clavien-Dindo classification, surgical time, border invasion, postoperative drainage/period, RRM performance, reconstruction type, patient's pre-surgical recurrence status, medical cost data, and follow-up data. - Subject satisfaction assessment: After 3 to 12 months (+-30 days) of final surgery, the subject was surveyed to evaluate satisfaction with robotic surgery. Follow the BREAST-Q Korean questionnaire for evaluation. - Cost effectiveness evaluation according to surgical method (option): The cost effectiveness of robotic surgery is evaluated by surveying the subject 3 to 12 months after the final surgery (+-30 days). Follow the EQ5D Korean. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05490433
Study type Interventional
Source Yonsei University
Contact Hyung Seok Park, MD, PhD
Phone 82-10-6760-2974
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 2022
Completion date June 2030

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