AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction

RecruitingNAAges 19 Years - 70 YearsFemaleYonsei University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction (IBR) conducted in conjunction with robot-assisted nipple-sparing mastectomy (RNSM). Study Design Overview This study is a prospective, multicenter, randomized clinical trial (ROM Trial) designed to compare the oncologic outcomes of robot-assisted nipple-sparing mastectomy (RNSM) with conventional nipple-sparing mastectomy (CNSM), which includes both traditional and open-chest approaches. Previous retrospective studies of robot-assisted endoscopic surgery have suggested a short learning curve, demonstrating technical feasibility and reproducibility even for less experienced surgeons. However, the absence of rigorously designed randomized clinical trials remains a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult women (โ‰ฅ19 years) scheduled to undergo therapeutic mastectomy for breast cancer who desire immediate breast reconstruction (IBR). * Breast cancer classified as clinical TNM stage 0 to IIIA, based on preoperative evaluation according to the 8th edition of the AJCC anatomic staging system. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Patients scheduled for breast-conserving surgery or deemed ineligible for immediate breast reconstruction (IBR). * Clinical evidence of nipple or skin involvement on preoperative evaluation. * Pregnant or breastfeeding women. * Tumors consisting exclusively of lobular carcinoma in situ (LCIS). * Paget's disease of the breast. * Inflammatory breast cancer. * Male breast cancer. * Clinical stage IIIB-IV disease on preoperative evaluation. * breast size equal to or larger than cup E * History of breast cancer or bilateral breast cancer (including metachronous or synchronous disease). * History of non-breast malignancy, with the exception of non-melanoma skin cancer or papillary/follicular thyroid carcinoma. * Special histologic subtypes of breast tumors (e.g., phyllodes tumor, sarcoma, lymphoma). * Age \>70 years. * American Society of Anesthesiologists (ASA) physical status classification grade โ‰ฅ4. * Inability to provide informed consent. * History of prior chest radiotherapy. * Patients who have not undergone preoperative testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), which is required for liability insurance coverage.
๐Ÿ’Š

What it tests

  • Robot-assisted Nipple-Sparing Mastectomy (RNSM)
  • Conventional nipple sparing mastectomy(CNSM)
๐Ÿ“

Where

17 sites
Samsung Changwon Medical Center
Changwon, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Myongji Hospital
Goyang-si, South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, South Korea
Kosin University Gospel Hospital
Pusan, South Korea
Chungnam National University Sejong Hospital
Sejong, South Korea

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy