Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial
Yonsei University
790 participants
Oct 26, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Adult women (≥19 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 Criteria17
- 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 ≥4.
- 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.
Interventions
Patients undergoing robot-assisted nipple-sparing mastectomy (RNSM) with immediate breast reconstruction (IBR) will be enrolled in this group. RNSM will be performed using robotic surgical platforms, including the da Vinci S, Si, X, Xi, and SP systems. The procedure will be conducted through an axillary or lateral chest wall incision. During surgery, posterior areolar tissue sampling for frozen section biopsy will be recommended. If suspicious lesions are detected at the superficial or posterior margins, frozen section biopsy of those lesions will also be performed. When tumor involvement of the nipple-areola complex (NAC), superficial margin, or posterior margin is confirmed by frozen section biopsy, additional resection including the skin and NAC, or postoperative radiotherapy, will be considered.
Patients who undergo conventional nipple-sparing mastectomy (CNSM) with immediate breast reconstruction (IBR) will be enrolled in this group. CNSM is performed without the use of robotic or endoscopic surgical systems, and all types of skin incisions are permitted. During surgery, posterior areolar tissue sampling for frozen section biopsy is recommended. If suspicious lesions suggesting tumor involvement are identified at the superficial or posterior margins, frozen section biopsy should also be performed. When frozen section biopsy confirms tumor involvement of the nipple-areola complex (NAC), superficial margin, or posterior margin, additional excision including the skin and NAC, or postoperative radiotherapy, will be considered.
Locations(17)
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NCT05490433