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

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.

Conditions

• Breast Cancer Classified as TNM Stage 0-IIIa

Interventions

PROCEDURE

Robot-assisted Nipple-Sparing Mastectomy (RNSM)

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.

PROCEDURE

Conventional nipple sparing mastectomy(CNSM)

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.

Sponsors & Collaborators

• Yonsei University

  lead OTHER

Principal Investigators

• Hyung Seok Park, MD, PhD · Yonsei University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-26

Primary Completion

2032-06-30

Completion

2032-06-30

Countries

• South Korea

Study Locations