Actively Recruiting
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
Led by Yonsei University · Updated on 2025-11-17
790
Participants Needed
17
Research Sites
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 major global barrier to the broader adoption of robotic breast surgery. In the ROM Trial, eligible patients who provide written informed consent will be randomly assigned in a 1:1 ratio to undergo either RNSM or CNSM. Participants will be blinded to group allocation until the day of surgery (single-blind design). Immediate breast reconstruction (IBR) will be performed in all patients, with the reconstruction method determined in consultation with the breast and/or plastic surgeon following mastectomy.
CONDITIONS
Official Title
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women (≥19 years) scheduled for therapeutic mastectomy for breast cancer who want immediate breast reconstruction
- Breast cancer classified as clinical TNM stage 0 to IIIA based on the 8th edition AJCC staging system
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Scheduled for breast-conserving surgery or ineligible for immediate breast reconstruction
- Clinical evidence of nipple or skin involvement on preoperative evaluation
- Pregnant or breastfeeding women
- Tumors made up only 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
- History of non-breast malignancy except non-melanoma skin cancer or papillary/follicular thyroid carcinoma
- Special tumor types like phyllodes tumor, sarcoma, lymphoma
- Age over 70 years
- American Society of Anesthesiologists (ASA) physical status grade 4 or higher
- Unable to provide informed consent
- History of prior chest radiotherapy
- No preoperative testing for hepatitis B, hepatitis C, and HIV required for insurance coverage
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Trial Site Locations
Total: 17 locations
1
Samsung Changwon Medical Center
Changwon, South Korea
Actively Recruiting
2
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
3
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Actively Recruiting
4
Yeungnam University Medical Center
Daegu, South Korea
Not Yet Recruiting
5
Myongji Hospital
Goyang-si, South Korea
Actively Recruiting
6
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, South Korea
Actively Recruiting
7
Kosin University Gospel Hospital
Pusan, South Korea
Actively Recruiting
8
Chungnam National University Sejong Hospital
Sejong, South Korea
Not Yet Recruiting
9
Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
10
Gangnam Severance Hospital
Seoul, South Korea
Not Yet Recruiting
11
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
12
Korea University Ansan Hospital
Seoul, South Korea
Not Yet Recruiting
13
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
14
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
15
Soonchunhyang University Hospital Seoul
Seoul, South Korea
Not Yet Recruiting
16
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
17
Yongin Severance Hospital
Yongin-si, South Korea
Actively Recruiting
Research Team
H
Hyung Seok Park, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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